Raise Your Laboratory Testing Benchmark!

Facebook X-twitter Instagram Linkedin Youtube

Raise Your Laboratory Testing Benchmark!

Facebook Twitter Instagram Linkedin Tm-material-icon-phone_iphone

Careers at Prompt Praxis Labs

Providing cost-effective options to physicians, pharmacies, and outsourcing facilities in an effort to ensure chemically safe and effective compounded preparations.

Analytical Testing

Analytical Testing
Analytical Development & Validation Services

Analytical Development & Validation Services
Formulation Development

Formulation Development
Ready to Analyze Test Methods

Ready To Analyze® Test Methods
Analytical Testing

Analytical Testing
Analytical Development & Validation Services

Analytical Development & Validation Services
Formulation Development

Formulation Development
Ready to Analyze Test Methods

Ready To Analyze® Test Methods

OUR CORE VALUES

The foundation of how we work and why clients trust us.

Professional and Respectful

We are professional, respectful, friendly, and courteous.

Committed and Honest

We are committed as a team and honest in our interactions.

Client-Driven and Transparent

We are client-driven, responsive, and transparent.

Accurate and Reliable

We deliver accurate, precise, quality analytical and micro-testing results as promised.

Positions AVAILABLE

Associate Scientist I (Microbiology)

Associate Scientist I - Microbiology Testing

The Associate Scientist I - Microbiology Testing supports Prompt Praxis Laboratories microbiology testing operations by performing routine and investigational microbiological testing in a cGMP-regulated laboratory environment. This role supports testing of drug substances, drug products, excipients, compounded sterile preparations, stability samples, and environmental monitoring samples.

This is an excellent opportunity for a recent graduate or early-career scientist to gain hands-on laboratory experience in pharmaceutical microbiology, aseptic technique, environmental monitoring, rapid sterility testing, bacterial endotoxin testing, and regulated documentation.

Location: Onsite - Vernon Hills, Illinois

About Prompt Praxis Laboratories

Prompt Praxis Laboratories (PPL), founded in 2011, is a women-owned analytical and microbiology lab specializing in rapid testing, analytical development, and comprehensive support services. Leveraging modern technology, automation, and advanced laboratory instrumentation, PPL delivers accurate, high-quality results for pharmaceutical, compounding pharmacy, medical device, veterinary product, and wellness industry clients.

Committed to scientific excellence, data integrity, and operational innovation, PPL provides cost-effective solutions that support safe, effective drug products. Join PPL and build a career defined by quality, compliance, and scientific growth.

Primary Responsibilities

Microbiological Testing Execution

  • Perform microbiological testing on excipients, APIs, finished products, compounded sterile preparations, and stability samples with close attention to timelines and documentation accuracy.
  • Prepare media, solutions, and samples in accordance with approved SOPs and proper aseptic technique.
  • Support environmental monitoring activities, including gowning, aseptic handling, and cleanroom behavior in line with qualification standards.
  • Learn and apply microbiology principles to analyze results, identify trends, and support data interpretation under supervision.

Equipment, Instrumentation, and Laboratory Readiness

  • Operate and maintain laboratory equipment and instrumentation, including ScanRDI and BET systems.
  • Support ongoing instrument calibration and maintenance activities.
  • Assist with inventory control and materials management, including receiving, quarantining, releasing, and proper disposal of laboratory materials.
  • Ensure efficient use of materials to minimize waste.
  • Follow all safety protocols and use required personal protective equipment.

Documentation, Compliance, and Quality Systems

  • Accurately document experimental work in laboratory notebooks and electronic systems in accordance with cGMP and internal policies.
  • Follow SOPs, laboratory protocols, company procedures, and regulatory standards consistently.
  • Assist in the development and execution of SOPs and protocols to support laboratory operations and technology transfers.
  • Contribute to a culture of quality, compliance, and continuous learning.

Collaboration and Professional Growth

  • Work collaboratively across teams to support microbiological testing programs and laboratory priorities.
  • Communicate clearly with colleagues and management regarding testing activities, documentation, and project needs.
  • Respond to changing priorities with flexibility and a positive attitude.
  • Continue building technical skills in a regulated, team-oriented laboratory environment.

Core Competencies

  • Technical Aptitude: Demonstrates understanding of microbiological methods, laboratory instrumentation, and aseptic techniques, and learns new tools and procedures quickly.
  • Attention to Detail: Maintains accurate records and performs tasks with precision in a regulated environment.
  • Collaboration: Works effectively as part of a cross-functional team and communicates clearly with colleagues and management.
  • Adaptability: Thrives in a fast-paced environment and responds to changing priorities with flexibility.
  • Compliance Mindset: Understands and follows cGMP, FDA, and ICH guidelines to help ensure work meets regulatory and quality standards.

Desired Qualifications

  • Bachelor's degree in Microbiology, Biology, Chemistry, or a related scientific discipline.
  • 0 to 3 years of experience in a cGMP microbiology or pharmaceutical laboratory setting.
  • Familiarity with microbiological methods and laboratory instrumentation, including BET, ScanRDI, endotoxin, or ELISA.
  • Proficiency with Microsoft Office Suite, including Word, Excel, Outlook, and PowerPoint.
  • Strong written and verbal communication skills.
  • Ability to follow SOPs and laboratory protocols consistently.
  • Strong organizational skills with the ability to manage multiple priorities.
  • Willingness to learn and grow in a regulated, team-oriented environment.
  • Experience in an ISO-5 cleanroom environment is a plus.

Working Conditions

  • This position is based onsite at Prompt Praxis Laboratories' Vernon Hills, Illinois facilities.
  • Travel between PPL locations may be required as needed.
  • Work is performed in a laboratory environment and may require personal protective equipment, including laboratory coats, gloves, safety glasses, and other required protective equipment.
  • The employee may be required to stand, walk, lift laboratory materials, and perform repetitive tasks associated with routine laboratory operations.

To Apply

Please send your resume to [email protected].

Associate Scientist II (Chemistry)

Associate Scientist II - Chemistry

The Associate Scientist II - Chemistry supports Prompt Praxis Laboratories analytical chemistry testing operations by executing routine and advanced chemical analyses in a cGMP-regulated laboratory environment. This role focuses on chromatographic and wet chemistry techniques including UPLC and HPLC analysis, sample preparation, and compendial testing of APIs, finished products, compounded preparations, and stability samples.

The Associate Scientist II applies sound scientific principles, established procedures, and quality systems to ensure timely, accurate, and compliant testing in support of client programs, stability studies, and internal initiatives. This role works collaboratively with Chemistry, QA, and cross-functional teams to maintain PPL’s high standards of quality, compliance, and service.

Location: Onsite

About Prompt Praxis Laboratories

Prompt Praxis Laboratories (PPL), founded in 2011, is a women-owned analytical and microbiology lab specializing in rapid testing, analytical development, and comprehensive support services. Leveraging modern technology and automation, PPL delivers accurate, high-quality results for Pharmaceutical, Compounding Pharmacy, and Medical Device clients.

Committed to scientific excellence, data integrity, and operational innovation, PPL provides cost-effective solutions that ensure safe, effective drug products. Join PPL and build a career defined by excellence and impact.

Primary Responsibilities

Analytical Chemistry Testing Execution

  • Perform routine and advanced analytical testing using chromatographic and wet chemistry techniques in accordance with approved SOPs, specifications, and cGMP requirements.
  • Execute testing using UPLC and HPLC systems and associated software such as Empower, including system setup, sequence creation, and data acquisition.
  • Prepare mobile phases, samples, standards, and reagents with attention to accuracy, traceability, and material conservation.
  • Support testing of raw materials, excipients, APIs, finished products, compounded sterile preparations, and stability samples.
  • Analyze, trend, and interpret analytical data and identify atypical or out-of-trend results for escalation per procedures.
  • Ensure accurate, contemporaneous documentation of all test activities in laboratory notebooks, worksheets, and electronic systems.

Documentation, Compliance, and Quality Systems

  • Maintain compliance with cGMPs, data integrity principles including ALCOA+, and PPL quality systems.
  • Prepare and maintain clear, accurate, and compliant laboratory documentation and records.
  • Support investigations including OOS, deviations, excursions, and CAPAs related to analytical testing.
  • Participate in method verification, validation, transfer, and robustness studies as assigned.
  • Contribute to SOP creation, review, and continuous improvement initiatives related to chemistry testing.

Equipment, Instrumentation, and Laboratory Readiness

  • Operate, maintain, and troubleshoot analytical instrumentation including UPLC and HPLC systems, balances, and general laboratory equipment.
  • Perform routine equipment checks, calibrations, and maintenance in accordance with SOPs and metrology requirements.
  • Maintain materials management processes including receiving, quarantine, inventory, and disposal.
  • Ensure proper handling, labeling, storage, and disposal of samples, reagents, and chemical waste.
  • Support laboratory organization, cleanliness, and audit readiness.

Collaboration and Continuous Improvement

  • Work closely with Chemistry leadership, QA, Client Services, and Operations to meet testing schedules and client commitments.
  • Effectively manage multiple priorities in a fast-paced laboratory environment with minimal supervision.
  • Apply scientific judgment to support continuous improvement, efficiency, and risk reduction initiatives.
  • Collaborate with senior scientists on method development, optimization, and technology transfer activities.
  • Participate in training and mentoring of junior staff as appropriate.

Desired Qualifications

  • Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related scientific discipline.
  • 3 to 5 years of experience in a cGMP-regulated analytical laboratory.
  • Hands-on experience with chromatographic techniques including UPLC and HPLC and analytical instrumentation.
  • Familiarity with Empower or similar chromatography data systems.
  • Working knowledge of wet chemistry techniques and compendial testing.
  • Understanding of FDA regulations, cGMPs, and data integrity expectations.
  • Strong documentation skills with the ability to generate clear, accurate, and compliant records.
  • Proficiency with Microsoft Office applications.
  • Excellent attention to detail, organizational skills, and ability to manage competing priorities.
  • Effective verbal and written communication skills.
  • Ability to work independently and collaboratively in a team-oriented laboratory environment.

How to Apply

For immediate consideration, please send your resume to:

[email protected]

Microbiology Group Leader

Microbiology Group Leader

The Microbiology Group Leader supports Prompt Praxis Laboratories microbiology testing operations by overseeing daily department activities, managing testing schedules, supporting investigations, and helping maintain compliance in a cGMP-regulated laboratory environment.

This role provides leadership for rapid sterility testing, traditional sterility testing, bacterial endotoxin testing, environmental monitoring, aseptic technique programs, gowning certification, and other microbiology-based laboratory services. The Microbiology Group Leader works closely with Quality Assurance, laboratory leadership, and cross-functional teams to ensure accurate testing, strong documentation, audit readiness, and continuous improvement.

Location: Onsite - Vernon Hills, Illinois

About Prompt Praxis Laboratories

Prompt Praxis Laboratories (PPL), founded in 2011, is a women-owned analytical and microbiology lab specializing in rapid testing, analytical development, and comprehensive support services. Leveraging modern technology, automation, and advanced laboratory instrumentation, PPL delivers accurate, high-quality results for pharmaceutical, compounding pharmacy, medical device, veterinary product, and wellness industry clients.

Committed to scientific excellence, data integrity, and operational innovation, PPL provides cost-effective solutions that support safe, effective drug products. Join PPL and build a career defined by quality, leadership, and meaningful scientific impact.

Primary Responsibilities

Microbiology Laboratory Leadership

  • Oversee daily operations and address the needs of the Microbiology Department.
  • Manage testing schedules, testing progress, data, and work quality.
  • Support department planning, prioritization, and project timelines.
  • Provide continuous improvement ideas to strengthen laboratory efficiency, quality, and compliance.
  • Assist in the implementation of new equipment, methods, room qualifications, utility qualifications, and related microbiology projects.

Microbiological Testing and Technical Support

  • Provide microbiology support for rapid sterility testing, including ScanRDI, traditional sterility testing, bacterial endotoxin testing, and other microbiological testing as required.
  • Apply strong knowledge of pharmaceutical microbiology, cleanroom environmental control, and microbiological testing methods.
  • Support environmental monitoring of clean rooms and utilities.
  • Participate in troubleshooting and out-of-specification investigations for the Microbiology Department.
  • Develop strong microbiology and investigational skills within the department.

Compliance, Documentation, and Quality Systems

  • Support compliance with ISO, FDA, USP, cGMP, and related regulatory expectations.
  • Help Quality Assurance establish and enforce quality standards in sample testing and documentation.
  • Revise and review SOPs, checklists, investigations, validations, and related technical documents.
  • Ensure documentation clearly defines the steps needed to complete required audit tasks.
  • Participate in client and internal audits based on the FDA System Based Inspection Policy and general cGMP expectations.

Training, Programs, and Inspection Support

  • Assist in the creation, implementation, and administration of microbiology-based programs, including training, gowning, and aseptic technique programs.
  • Represent Microbiology during regulatory inspections and respond to microbiology-related questions, issues, and solutions.
  • Respond to customer requests for information.
  • Develop professional and technical knowledge through continuing education, professional publications, networking, and industry participation.

Core Competencies

  • Leadership and Team Development: Guides team members and supports a positive, productive work environment focused on continuous improvement.
  • Regulatory Expertise: Demonstrates knowledge of ISO, FDA, USP, cGMP standards, and FDA System Based Inspection Policy.
  • Technical Proficiency: Applies expertise in pharmaceutical microbiology testing, including ScanRDI, traditional sterility, endotoxin testing, and environmental monitoring.
  • Problem Solving: Troubleshoots and resolves complex microbiological and operational challenges.
  • Communication and Documentation: Prepares clear technical documentation and communicates effectively during inspections, audits, and client interactions.

Desired Qualifications

  • Bachelor's degree in Microbiology.
  • 3+ years of directly related experience required.
  • Solid working knowledge of cGMPs and related quality systems.
  • Knowledge of pharmaceutical microbiology, including ScanRDI, traditional sterility, and endotoxin testing.
  • Experience in environmental control and monitoring of clean rooms and utilities.
  • Technical writing experience, including SOPs, investigations, and validations.
  • Strong organizational, oral communication, problem-solving, attention to detail, and interpersonal skills.
  • Proficiency with Microsoft Office, including Word, Excel, PowerPoint, and Outlook.
  • Ability to exercise initiative and judgment to solve problems of varying difficulty.

To Apply

Please send your resume to [email protected].

Quality Assurance Reviewer I (Microbiology)

Quality Assurance Reviewer I (Microbiology)

Documents experiments in accordance with company policies, procedures, and protocols demonstrating a working knowledge of microbiology tasks and the application of scientific principles and technologies. Works collaboratively with the team to develop and implement microbiological test procedures that support drug substance, drug product, excipient, compounded sterile preparation activities, and microbiological sample testing.

About Prompt Praxis Laboratories

Prompt Praxis Laboratories (PPL), founded in 2011, is a women-owned analytical and microbiology lab specializing in rapid testing, analytical development, and comprehensive support services. Leveraging modern technology and automation, PPL delivers accurate, high-quality results for Pharmaceutical, Compounding Pharmacy, and Medical Device clients.

Committed to scientific excellence, data integrity, and operational innovation, PPL provides cost-effective solutions that ensure safe, effective drug products. PPL offers a competitive total rewards package, including 401(k) matching, comprehensive employee benefits, and a commitment to ongoing professional development. Join PPL and build a career defined by excellence and impact.

Primary Responsibilities

  • Operates the materials management system integrating receiving, quarantine, release, inventory, and disposal mechanisms.
  • Prepares solutions, samples, and standards for use in procedures and has responsibility for preventing waste or loss of materials.
  • Meet requirements for annual gowning and aseptic handling certifications.
  • Conduct environmental monitoring as needed.
  • Maintains proper waste disposal handling and record keeping.
  • Participates in the execution and optimization of Standard Operating Procedures (SOPs) for equipment and instrumentation per cGMPs.
  • Correctly analyzes and interprets the outcome of experiments.
  • Prepares and assembles documentation such as entries into laboratory notebooks and maintains proper records per relevant SOPs and policies.
  • Collaborates with supporting management for assigned tasks, including technology transfer.
  • Ability to learn regulations, legal requirements, policies, and procedures relevant to areas of responsibility.
  • Applies knowledge to ensure safe and compliant practices, manage risk, and maximize opportunities for projects to succeed.
  • Learn and become proficient with ScanRDI, BET, and various other microbiological techniques.
  • Performs routine microbiological tests of excipients, APIs, finished products, compounded sterile preparations, and stability samples.
  • Create and maintain clear and concise lab records and documentation.
  • Responsible for the timely execution of lab analysis and related documentation.
  • Supports daily analysis and stability study activities with significant supervision.

Desired Qualifications

  • BA or BS degree in Science, Biology, Medicinal Chemistry, or Chemistry.
  • 0 to 3 years of cGMP laboratory experience or equivalent.
  • Familiarity with microbiological instrumentation theory and practice.
  • Computer skills including Microsoft Office: Word, Excel, PowerPoint, and Outlook.
  • Good oral and written communication skills with the ability to communicate clearly and concisely.
  • Ability to learn, comprehend, and follow procedures in a cGMP environment.
  • Ability to exercise a degree of initiative and judgment to solve problems of medium difficulty.
  • Good organizational skills and strong attention to detail.
  • Ability to effectively function in a fast-paced work environment.
  • Learn cGMPs, FDA, and ICH guidelines.

How to Apply

For immediate consideration, please send your resume to:
[email protected]

Quality Assurance Reviewer II (Chemistry)

Quality Assurance Reviewer II (Chemistry)

The Quality Assurance Associate II supports Prompt Praxis Laboratories quality assurance program by performing independent scientific review of laboratory testing data generated by analytical chemistry laboratories operating in a cGMP-regulated environment. This role applies strong scientific understanding, regulatory knowledge, and data integrity principles to ensure laboratory testing records are accurate, compliant, and defensible prior to release of results to clients.

The QA Associate II collaborates closely with QC analysts, laboratory leadership, and cross-functional teams to verify that testing activities adhere to approved methods, SOPs, and regulatory requirements. This position is ideal for candidates with experience in analytical chemistry who are interested in applying their scientific expertise in a quality assurance capacity.

Location: Onsite

About Prompt Praxis Laboratories

Prompt Praxis Laboratories (PPL), founded in 2011, is a women-owned analytical and microbiology lab specializing in rapid testing, analytical development, and comprehensive support services. Leveraging modern technology and automation, PPL delivers accurate, high-quality results for Pharmaceutical, Compounding Pharmacy, and Medical Device clients.

Committed to scientific excellence, data integrity, and operational innovation, PPL provides cost-effective solutions that ensure safe, effective drug products. Join PPL and build a career defined by excellence and impact.

Primary Responsibilities

Quality Assurance Data Review

  • Perform independent review of analytical chemistry testing records to ensure compliance with cGMP requirements and internal quality systems.
  • Verify accuracy, completeness, and integrity of laboratory data packages including raw data, calculations, chromatograms, worksheets, and supporting documentation.
  • Confirm that testing was performed according to approved methods, SOPs, and client specifications.
  • Ensure proper documentation of laboratory activities, deviations, and corrections in accordance with regulatory expectations.
  • Review analytical data generated from instrumentation to confirm accuracy and method compliance.
  • Verify instrument methods, chromatographic conditions, and run parameters align with approved analytical methods.
  • Confirm correct columns, standards, reagents, and solutions were used during testing.
  • Ensure analytical calculations, dilution factors, and assay determinations are accurate and consistent with method requirements.

Data Integrity and Regulatory Compliance

  • Ensure laboratory documentation complies with cGMP and ALCOA+ data integrity principles.
  • Review records for completeness, accuracy, and contemporaneous documentation.
  • Verify audit trail compliance and ensure no unauthorized data modifications occur.
  • Escalate potential deviations, investigations, or non-conformances identified during review.
  • Support laboratory readiness for regulatory inspections and client audits.

Collaboration and Continuous Improvement

  • Collaborate with Quality Assurance, QC laboratory teams, and Operations to support efficient and compliant workflows.
  • Communicate review findings clearly and professionally to laboratory personnel.
  • Participate in continuous improvement initiatives focused on strengthening laboratory quality systems and efficiency.
  • Support development and improvement of SOPs, data review processes, and quality documentation practices.
  • Contribute to maintaining a strong culture of quality and scientific integrity.

Desired Qualifications

  • Bachelor’s degree in Chemistry or a related life science discipline.
  • 3 to 5 years of experience working in a cGMP-regulated laboratory environment.
  • Strong experience with HPLC, UPLC, chromatography systems, analytical software (e.g., Empower), and Excel-based calculations.
  • Deep understanding of analytical methods and laboratory workflows.
  • Strong knowledge of cGMP, FDA, and ICH guidelines.
  • Ability to interpret complex data and assess impact on results.
  • Effective written and verbal communication skills.
  • Proficiency with Microsoft Office applications.
  • Ability to manage multiple priorities in a fast-paced environment.
  • Ability to work independently while collaborating effectively with cross-functional teams.

How to Apply

For immediate consideration, please send your resume to:

[email protected]

Quality Assurance Manager (Chemistry)

Quality Assurance Manager (Chemistry)

The Chemistry Quality Assurance Manager is responsible for final quality review and disposition of chemistry testing data supporting batch release for compounded and pharmaceutical products. This role serves as the QA authority for batch certification, ensuring all analytical results, investigations, and documentation meet cGMP, USP, and FDA expectations prior to product release.

This position bridges Quality Assurance and Chemistry QC, providing independent oversight of analytical data, enforcing data integrity standards, and ensuring that all batch-related decisions are scientifically justified, compliant, and inspection-ready.

Hours / Location: Full Time, Onsite

About Prompt Praxis Laboratories

Prompt Praxis Laboratories (PPL), founded in 2011, is a women-owned analytical and microbiology lab specializing in rapid testing, analytical development, and comprehensive support services. Leveraging modern technology and automation, PPL delivers accurate, high-quality results for Pharmaceutical, Compounding Pharmacy, and Medical Device clients.

Committed to scientific excellence, data integrity, and operational innovation, PPL provides cost-effective solutions that ensure safe, effective drug products. PPL offers a competitive total rewards package, including 401(k) matching, comprehensive employee benefits, and ongoing professional development.

Core Competencies

Batch Disposition and Product Release Decision-Making; Chemistry Data Review and Interpretation; cGMP and Regulatory Compliance; Investigation and Risk Assessment; Data Integrity and Documentation Excellence; Cross-Functional Influence; Audit Readiness and Inspection Defense; Team Leadership and Accountability

Primary Responsibilities

Batch Release and Disposition Authority

  • Serve as the QA approver for batch release, ensuring all testing, documentation, and investigations are complete and compliant.
  • Perform final disposition decisions for in-process, finished product, and stability batches.
  • Ensure no product is released until all data, deviations, and investigations are fully resolved.
  • Assess product impact and patient risk associated with atypical or out-of-trend results.

Chemistry Data Review and Oversight

  • Conduct independent QA review of analytical data including assay, impurities, stability, and physical testing results.
  • Verify accuracy, completeness, and traceability of raw data and reported results.
  • Ensure analytical methods and execution meet validated and regulatory standards.
  • Provide critical evaluation of analyst conclusions to ensure scientific soundness.

Investigations, Deviations, and CAPA

  • Review and approve OOS, OOT, deviations, and laboratory investigations impacting batch release.
  • Ensure investigations establish clear root cause and effective CAPAs.
  • Partner with QC and QA teams to ensure investigations are timely and defensible.
  • Prevent premature batch release where investigation outcomes remain unresolved.

Quality Systems and Compliance

  • Ensure adherence to cGMP, FDA guidance, and USP standards for batch release testing.
  • Review and approve SOPs related to data review and batch disposition.
  • Maintain strong knowledge of regulatory expectations related to data integrity.
  • Support continuous improvement of quality systems and workflows.

Cross-Functional Collaboration

  • Partner with Chemistry QC, Operations, Sample Management, and Client Services to align on priorities and timelines.
  • Provide QA guidance on analytical execution and investigation strategy.
  • Support communication of batch-related quality decisions to stakeholders and clients.

Audit and Inspection Readiness

  • Serve as a subject matter expert during audits and regulatory inspections.
  • Defend batch disposition decisions and data review practices.
  • Ensure all documentation is inspection-ready and compliant.

Team Leadership

  • Lead and manage QA staff supporting batch release.
  • Establish scheduling to support throughput and release commitments.
  • Provide coaching and mentoring to develop technical capability and decision-making.
  • Drive accountability, performance management, and team engagement.

Continuous Improvement and Leadership

  • Identify trends in batch failures and analytical issues to drive improvements.
  • Lead initiatives to enhance right-first-time performance and efficiency.
  • Promote a culture of quality ownership and data integrity.

Desired Qualifications

  • Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or related discipline.
  • 7 to 10 years of QA or QC experience in a regulated environment.
  • Strong expertise in analytical chemistry including HPLC, UPLC, GC, KF, UV-Vis, and FTIR.
  • Experience with batch release, product disposition, and QA data review.
  • 3 to 5 years of leadership experience.
  • Strong experience with investigations, CAPA, and data integrity.
  • Experience supporting FDA inspections and client audits.
  • Excellent technical writing and documentation review skills.
  • Strong scientific judgment and ability to manage competing priorities.

How to Apply

For immediate consideration, please send your resume to:

[email protected]

Interested in Future Opportunities?

We welcome inquiries beyond our current openings. If you do not see a position that matches your experience at this time, you are still encouraged to submit your resume for future consideration.

Please email your resume and cover letter to [email protected] .  All submissions will be kept on file for future opportunities.

 

How to Apply for Open Positions

To apply for any current openings, please send your resume and cover letter to [email protected] .

In the subject line, clearly state the position you are applying for (for example: Application for Laboratory Technician). This helps to make sure that your application is routed correctly.

Positions AVAILABLE

Associate Scientist I - Micro

Associate Scientist I - Micro

Documents experiments in accordance with company policies, procedures, and protocols demonstrating a working knowledge of microbiology tasks and the application of scientific principles and technologies. Works collaboratively with the team to develop and implement microbiological test procedures that support drug substance, drug product, excipient, compounded sterile preparation activities, and microbiological sample testing.

About Prompt Praxis Laboratories

Prompt Praxis Laboratories (PPL), founded in 2011, is a women-owned analytical and microbiology lab specializing in rapid testing, analytical development, and comprehensive support services. Leveraging modern technology and automation, PPL delivers accurate, high-quality results for Pharmaceutical, Compounding Pharmacy, and Medical Device clients.

Committed to scientific excellence, data integrity, and operational innovation, PPL provides cost-effective solutions that ensure safe, effective drug products. PPL offers a competitive total rewards package, including 401(k) matching, comprehensive employee benefits, and a commitment to ongoing professional development. Join PPL and build a career defined by excellence and impact.

Primary Responsibilities

  • Operates the materials management system integrating receiving, quarantine, release, inventory, and disposal mechanisms.
  • Prepares solutions, samples, and standards for use in procedures and has responsibility for preventing waste or loss of materials.
  • Meet requirements for annual gowning and aseptic handling certifications.
  • Conduct environmental monitoring as needed.
  • Maintains proper waste disposal handling and record keeping.
  • Participates in the execution and optimization of Standard Operating Procedures (SOPs) for equipment and instrumentation per cGMPs.
  • Correctly analyzes and interprets the outcome of experiments.
  • Prepares and assembles documentation such as entries into laboratory notebooks and maintains proper records per relevant SOPs and policies.
  • Collaborates with supporting management for assigned tasks, including technology transfer.
  • Ability to learn regulations, legal requirements, policies, and procedures relevant to areas of responsibility.
  • Applies knowledge to ensure safe and compliant practices, manage risk, and maximize opportunities for projects to succeed.
  • Learn and become proficient with ScanRDI, BET, and various other microbiological techniques.
  • Performs routine microbiological tests of excipients, APIs, finished products, compounded sterile preparations, and stability samples.
  • Create and maintain clear and concise lab records and documentation.
  • Responsible for the timely execution of lab analysis and related documentation.
  • Supports daily analysis and stability study activities with significant supervision.

Desired Qualifications

  • BA or BS degree in Science, Biology, Medicinal Chemistry, or Chemistry.
  • 0 to 3 years of cGMP laboratory experience or equivalent.
  • Familiarity with microbiological instrumentation theory and practice.
  • Computer skills including Microsoft Office: Word, Excel, PowerPoint, and Outlook.
  • Good oral and written communication skills with the ability to communicate clearly and concisely.
  • Ability to learn, comprehend, and follow procedures in a cGMP environment.
  • Ability to exercise a degree of initiative and judgment to solve problems of medium difficulty.
  • Good organizational skills and strong attention to detail.
  • Ability to effectively function in a fast-paced work environment.
  • Learn cGMPs, FDA, and ICH guidelines.

How to Apply

For immediate consideration, please send your resume to: [email protected]

IT Systems Administrator

IT Systems Administrator

The IT Systems Administrator is responsible for the administration, security, and support of Prompt Praxis Laboratories Windows- and Azure-based IT environment, with a strong focus on laboratory operations and regulated systems. This hands-on role supports end users, laboratory instruments, and business systems while ensuring reliability, cybersecurity, scalability, and compliance with cGMP and data integrity expectations. The position partners closely with Laboratory Operations, Quality, and external IT vendors to enable efficient, secure, and compliant laboratory workflows.

Hours / Location: Full Time, Onsite

About Prompt Praxis Laboratories

Prompt Praxis Laboratories (PPL), founded in 2011, is a women-owned analytical and microbiology lab specializing in rapid testing, analytical development, and comprehensive support services. Leveraging modern technology and automation, PPL delivers accurate, high-quality results for Pharmaceutical, Compounding Pharmacy, and Medical Device clients. Committed to scientific excellence, data integrity, and operational innovation, PPL provides cost-effective solutions that ensure safe, effective drug products.

PPL offers a competitive total rewards package, including 401(k) matching, comprehensive employee benefits, and a commitment to ongoing professional development. Join PPL and build a career defined by excellence and impact.

Primary Responsibilities

IT Systems and Infrastructure Administration

  • Administer and support Windows-based endpoints and servers in a hybrid Azure and on-prem environment.
  • Manage Azure Active Directory (Entra ID), user access, role-based permissions, and identity lifecycle management.
  • Support Microsoft 365 services including Exchange Online, SharePoint, OneDrive, Teams, and collaboration tools.
  • Maintain system availability, performance, patching, and backups across infrastructure components.

Laboratory Systems and Instrument Support

  • Serve as primary IT liaison for laboratory instruments and laboratory information systems including LIMS, CDS, SDMS, and ELN platforms.
  • Coordinate installation, configuration, validation support, and troubleshooting for laboratory software and hardware.
  • Partner with vendors and internal teams to support regulated applications such as chromatography data systems and environmental monitoring tools.
  • Ensure laboratory systems align with data integrity and security expectations, including ALCOA+ principles.

Helpdesk and End-User Support

  • Act as a primary point of contact for IT issues across all departments.
  • Provide Tier 1 and Tier 2 helpdesk support for hardware, software, network, and access issues.
  • Document incidents, resolutions, and standard solutions in a centralized knowledge base.
  • Train and support users with varying levels of technical proficiency in a fast-paced laboratory environment.

Cybersecurity, Compliance, and Risk Management

  • Support endpoint security, identity protection, MFA, conditional access, and vulnerability remediation.
  • Assist with access reviews, audit preparation, and evidence collection related to IT systems.
  • Identify, document, and escalate IT risks observed during periodic system reviews.
  • Ensure IT practices align with cGMP, FDA, DEA, and internal quality system requirements.

IT Projects and Continuous Improvement

  • Participate in projects supporting laboratory expansion, new instruments, system upgrades, and process automation.
  • Support cloud migration initiatives and modernization of legacy systems.
  • Recommend improvements to system reliability, scalability, security, and user experience.
  • Collaborate with external MSPs, security vendors, and application providers as needed.

Desired Qualifications

Required

  • BA or BS degree in Information Technology, Computer Science, or equivalent experience.
  • Five or more years of experience in IT systems administration or enterprise IT support.
  • Strong experience with Windows 10 and 11, Windows Server, and Microsoft 365.
  • Hands-on experience with Azure and Entra ID, identity management, and cloud-based services.
  • Solid understanding of networking fundamentals, endpoint management, and IT security best practices.
  • Ability to manage an interrupt-driven workload with strong prioritization and documentation skills.

Preferred

  • Experience supporting regulated laboratory or healthcare environments.
  • Familiarity with laboratory systems such as LIMS, ELN, and CDS platforms including Empower, NuGenesis, or ScanRDI.
  • Experience with endpoint management tools such as Intune, MECM, or equivalent.
  • Working knowledge of SQL-based applications and system integrations.
  • Relevant certifications such as Microsoft Azure Administrator, Microsoft 365, Security+, or equivalent.
  • Strong service orientation with the ability to communicate clearly with scientific and non-technical staff.
  • Self-directed, dependable, and comfortable working independently.

How to Apply

For immediate consideration, please send your resume to: [email protected]

Lab Support Technician

ABOUT PROMPT PRAXIS LABORATORIES

Prompt Praxis Laboratories (PPL), founded in 2011, is a women-owned analytical and microbiology lab specializing in rapid testing, analytical development, and comprehensive support services. Leveraging modern technology and automation, PPL delivers accurate, high-quality results for Pharmaceutical, Compounding Pharmacy, and Medical Device clients. Committed to scientific excellence, data integrity, and operational innovation, PPL provides cost-effective solutions that ensure safe, effective drug products. Join PPL and build a career defined by excellence and impact.

POSITION DESCRIPTION

The Lab Support Technician role supports PPL’s analytical and microbiology laboratory operations by performing sample management, inventory coordination, and inter-site logistics responsibilities across PPL locations. This role is critical to ensuring samples, materials, and supplies move efficiently, securely, and compliantly throughout their full lifecycle. This role also works closely with Scientists, Analysts, and Operations leadership to ensure laboratories are well supplied, organized, compliant, and positioned to support timely and accurate testing. The Laboratory Support Technician plays a critical role in maintaining laboratory readiness, safety, and operational efficiency.

LOCATION: On Site (Multi-site travel required)

PRIMARY RESPONSIBILITIES

Sample Receiving, Handling & Tracking

  • Receive incoming client samples and internal materials, ensuring accurate log-in, labeling verification, and documentation in accordance with approved SOPs.
  • Inspect samples upon receipt for integrity, proper packaging, and labeling accuracy; escalate discrepancies per established procedures.
  • Maintain strict chain-of-custody and location accuracy for all samples throughout receiving, storage, transport, testing, retention, and disposal stages.
  • Ensure proper segregation of samples by status (e.g., received, quarantined, in testing, on-hold, completed, retained, disposed).
  • Coordinate with laboratory teams to ensure timely and accurate routing of samples to appropriate testing locations.

Inter-Site Logistics

  • Safely operate a company vehicle to transport samples, materials, supplies, and equipment between multiple PPL sites.
  • Perform scheduled and ad hoc sample transfers while maintaining temperature, handling, and documentation requirements.
  • Ensure vehicles are maintained in clean, compliant condition; perform basic vehicle inspections and report maintenance needs.
  • Adhere to all safety, DOT, and company driving policies.

Inventory & Materials Management

  • Support inventory management activities including tracking, stocking, and replenishment of laboratory and operations supplies.
  • Coordinate with Operations and Laboratory leadership to ensure appropriate stock levels are maintained across sites.
  • Organize storage areas to ensure materials are clearly labeled, accessible, and audit-ready.

Documentation, Compliance & Safety

  • Accurately complete all required logs, checklists, and documentation related to sample handling, transport, and inventory.
  • Follow all applicable SOPs, quality policies, and safety procedures within a regulated laboratory environment.
  • Support audit readiness by maintaining organized records and traceable sample movement.

DESIRED QUALIFICATIONS

  • High school diploma or equivalent required; associate degree or logistics/operations experience preferred.
  • Prior experience in logistics, warehouse operations, laboratory support, healthcare, or regulated environments preferred.
  • Valid driver’s license with clean driving record; experience driving a box van or similar commercial vehicle strongly preferred.
  • Ability to lift, move, and transport materials and sample containers as required.
  • Strong organizational skills and attention to detail.
  • Ability to follow written procedures and maintain accurate documentation.
  • Effective communication skills and ability to work collaboratively across teams.
  • Comfortable working in a fast-paced, multi-site operational environment.

How to Apply

For immediate consideration, please send your resume to: [email protected]

Quality Assurance Associate Scientist II (Chemistry)

Quality Assurance Reviewer Associate Scientist II (Chemistry)

The Quality Assurance Associate II supports Prompt Praxis Laboratories quality assurance program by performing independent scientific review of laboratory testing data generated by analytical chemistry laboratories operating in a cGMP-regulated environment. This role applies strong scientific understanding, regulatory knowledge, and data integrity principles to ensure laboratory testing records are accurate, compliant, and defensible prior to release of results to clients.

The QA Associate II collaborates closely with QC analysts, laboratory leadership, and cross-functional teams to verify that testing activities adhere to approved methods, SOPs, and regulatory requirements. This position is ideal for candidates with experience in analytical chemistry who are interested in applying their scientific expertise in a quality assurance capacity.

Location: Onsite

About Prompt Praxis Laboratories

Prompt Praxis Laboratories (PPL), founded in 2011, is a women-owned analytical and microbiology lab specializing in rapid testing, analytical development, and comprehensive support services. Leveraging modern technology and automation, PPL delivers accurate, high-quality results for Pharmaceutical, Compounding Pharmacy, and Medical Device clients.

Committed to scientific excellence, data integrity, and operational innovation, PPL provides cost-effective solutions that ensure safe, effective drug products. Join PPL and build a career defined by excellence and impact.

Primary Responsibilities

Quality Assurance Data Review

  • Perform independent review of analytical chemistry testing records to ensure compliance with cGMP requirements and internal quality systems.
  • Verify accuracy, completeness, and integrity of laboratory data packages including raw data, calculations, chromatograms, worksheets, and supporting documentation.
  • Confirm that testing was performed according to approved methods, SOPs, and client specifications.
  • Ensure proper documentation of laboratory activities, deviations, and corrections in accordance with regulatory expectations.
  • Review analytical data generated from analytical instrumentation to confirm accuracy and method compliance.
  • Verify instrument methods, chromatographic conditions, and run parameters align with approved analytical methods.
  • Confirm correct columns, standards, reagents, and solutions were used during testing.
  • Ensure analytical calculations, dilution factors, and assay determinations are accurate and consistent with method requirements.

Data Integrity and Regulatory Compliance

  • Ensure laboratory documentation complies with cGMP and ALCOA+ data integrity principles.
  • Review laboratory records for completeness, accuracy, and contemporaneous documentation.
  • Verify audit trail compliance and ensure no unauthorized data modifications occur.
  • Escalate potential deviations, laboratory investigations, or non-conformances when identified during review.
  • Support laboratory readiness for regulatory inspections and client audits.

Collaboration and Continuous Improvement

  • Collaborate with Quality Assurance, QC laboratory teams, and Operations to support efficient and compliant testing workflows.
  • Communicate review findings clearly and professionally to laboratory personnel.
  • Participate in continuous improvement initiatives focused on strengthening laboratory quality systems and operational efficiency.
  • Support development and improvement of SOPs, data review processes, and quality documentation practices.
  • Contribute to maintaining a strong culture of quality and scientific integrity within the laboratory.

Desired Qualifications

  • Bachelor's degree in Chemistry or a related life science discipline.
  • 3 to 5 years of experience working in a cGMP-regulated laboratory environment.
  • Strong experience with HPLC, UPLC, chromatography systems, analytical software such as Empower, and Excel-based calculations and data analysis.
  • Deep understanding of analytical methods and laboratory workflows.
  • Strong knowledge of cGMP, FDA, and ICH guidelines.
  • Ability to interpret complex data and assess impact on results.
  • Effective written and verbal communication skills.
  • Proficiency with Microsoft Office applications including Word, Excel, PowerPoint, and Outlook.
  • Ability to manage multiple priorities in a fast-paced laboratory environment.
  • Ability to work independently while collaborating effectively with cross-functional teams.

How to Apply

For immediate consideration, please send your resume to:

[email protected]

Quality Assurance Reviewer - Associate Scientist II (Chemistry)

Quality Assurance Associate Scientist II (Chemistry)

The Quality Assurance Associate II supports Prompt Praxis Laboratories quality assurance program by performing independent scientific review of laboratory testing data generated by analytical chemistry laboratories operating in a cGMP-regulated environment. This role applies strong scientific understanding, regulatory knowledge, and data integrity principles to ensure laboratory testing records are accurate, compliant, and defensible prior to release of results to clients.

The QA Associate II collaborates closely with QC analysts, laboratory leadership, and cross-functional teams to verify that testing activities adhere to approved methods, SOPs, and regulatory requirements. This position is ideal for candidates with experience in analytical chemistry who are interested in applying their scientific expertise in a quality assurance capacity.

Location: Onsite

About Prompt Praxis Laboratories

Prompt Praxis Laboratories (PPL), founded in 2011, is a women-owned analytical and microbiology lab specializing in rapid testing, analytical development, and comprehensive support services. Leveraging modern technology and automation, PPL delivers accurate, high-quality results for Pharmaceutical, Compounding Pharmacy, and Medical Device clients.

Committed to scientific excellence, data integrity, and operational innovation, PPL provides cost-effective solutions that ensure safe, effective drug products. Join PPL and build a career defined by excellence and impact.

Primary Responsibilities

Quality Assurance Data Review

  • Perform independent review of analytical chemistry testing records to ensure compliance with cGMP requirements and internal quality systems.
  • Verify accuracy, completeness, and integrity of laboratory data packages including raw data, calculations, chromatograms, worksheets, and supporting documentation.
  • Confirm that testing was performed according to approved methods, SOPs, and client specifications.
  • Ensure proper documentation of laboratory activities, deviations, and corrections in accordance with regulatory expectations.
  • Review analytical data generated from instrumentation to confirm accuracy and method compliance.
  • Verify instrument methods, chromatographic conditions, and run parameters align with approved analytical methods.
  • Confirm correct columns, standards, reagents, and solutions were used during testing.
  • Ensure analytical calculations, dilution factors, and assay determinations are accurate and consistent with method requirements.

Data Integrity and Regulatory Compliance

  • Ensure laboratory documentation complies with cGMP and ALCOA+ data integrity principles.
  • Review records for completeness, accuracy, and contemporaneous documentation.
  • Verify audit trail compliance and ensure no unauthorized data modifications occur.
  • Escalate potential deviations, investigations, or non-conformances identified during review.
  • Support laboratory readiness for regulatory inspections and client audits.

Collaboration and Continuous Improvement

  • Collaborate with Quality Assurance, QC laboratory teams, and Operations to support efficient and compliant workflows.
  • Communicate review findings clearly and professionally to laboratory personnel.
  • Participate in continuous improvement initiatives focused on strengthening laboratory quality systems and efficiency.
  • Support development and improvement of SOPs, data review processes, and quality documentation practices.
  • Contribute to maintaining a strong culture of quality and scientific integrity.

Desired Qualifications

  • Bachelor’s degree in Chemistry or a related life science discipline.
  • 3 to 5 years of experience working in a cGMP-regulated laboratory environment.
  • Strong experience with HPLC, UPLC, chromatography systems, analytical software (e.g., Empower), and Excel-based calculations.
  • Deep understanding of analytical methods and laboratory workflows.
  • Strong knowledge of cGMP, FDA, and ICH guidelines.
  • Ability to interpret complex data and assess impact on results.
  • Effective written and verbal communication skills.
  • Proficiency with Microsoft Office applications.
  • Ability to manage multiple priorities in a fast-paced environment.
  • Ability to work independently while collaborating effectively with cross-functional teams.

How to Apply

For immediate consideration, please send your resume to:

[email protected]

Quality Assurance Manager (Chemistry)

Quality Assurance Manager (Chemistry)

The Chemistry Quality Assurance Manager is responsible for final quality review and disposition of chemistry testing data supporting batch release for compounded and pharmaceutical products. This role serves as the QA authority for batch certification, ensuring all analytical results, investigations, and documentation meet cGMP, USP, and FDA expectations prior to product release.

This position bridges Quality Assurance and Chemistry QC, providing independent oversight of analytical data, enforcing data integrity standards, and ensuring that all batch-related decisions are scientifically justified, compliant, and inspection-ready.

Hours / Location: Full Time, Onsite

About Prompt Praxis Laboratories

Prompt Praxis Laboratories (PPL), founded in 2011, is a women-owned analytical and microbiology lab specializing in rapid testing, analytical development, and comprehensive support services. Leveraging modern technology and automation, PPL delivers accurate, high-quality results for Pharmaceutical, Compounding Pharmacy, and Medical Device clients.

Committed to scientific excellence, data integrity, and operational innovation, PPL provides cost-effective solutions that ensure safe, effective drug products. PPL offers a competitive total rewards package, including 401(k) matching, comprehensive employee benefits, and ongoing professional development.

Core Competencies

Batch Disposition and Product Release Decision-Making; Chemistry Data Review and Interpretation; cGMP and Regulatory Compliance; Investigation and Risk Assessment; Data Integrity and Documentation Excellence; Cross-Functional Influence; Audit Readiness and Inspection Defense; Team Leadership and Accountability

Primary Responsibilities

Batch Release and Disposition Authority

  • Serve as the QA approver for batch release, ensuring all testing, documentation, and investigations are complete and compliant.
  • Perform final disposition decisions for in-process, finished product, and stability batches.
  • Ensure no product is released until all data, deviations, and investigations are fully resolved.
  • Assess product impact and patient risk associated with atypical or out-of-trend results.

Chemistry Data Review and Oversight

  • Conduct independent QA review of analytical data including assay, impurities, stability, and physical testing results.
  • Verify accuracy, completeness, and traceability of raw data and reported results.
  • Ensure analytical methods and execution meet validated and regulatory standards.
  • Provide critical evaluation of analyst conclusions to ensure scientific soundness.

Investigations, Deviations, and CAPA

  • Review and approve OOS, OOT, deviations, and laboratory investigations impacting batch release.
  • Ensure investigations establish clear root cause and effective CAPAs.
  • Partner with QC and QA teams to ensure investigations are timely and defensible.
  • Prevent premature batch release where investigation outcomes remain unresolved.

Quality Systems and Compliance

  • Ensure adherence to cGMP, FDA guidance, and USP standards for batch release testing.
  • Review and approve SOPs related to data review and batch disposition.
  • Maintain strong knowledge of regulatory expectations related to data integrity.
  • Support continuous improvement of quality systems and workflows.

Cross-Functional Collaboration

  • Partner with Chemistry QC, Operations, Sample Management, and Client Services to align on priorities and timelines.
  • Provide QA guidance on analytical execution and investigation strategy.
  • Support communication of batch-related quality decisions to stakeholders and clients.

Audit and Inspection Readiness

  • Serve as a subject matter expert during audits and regulatory inspections.
  • Defend batch disposition decisions and data review practices.
  • Ensure all documentation is inspection-ready and compliant.

Team Leadership

  • Lead and manage QA staff supporting batch release.
  • Establish scheduling to support throughput and release commitments.
  • Provide coaching and mentoring to develop technical capability and decision-making.
  • Drive accountability, performance management, and team engagement.

Continuous Improvement and Leadership

  • Identify trends in batch failures and analytical issues to drive improvements.
  • Lead initiatives to enhance right-first-time performance and efficiency.
  • Promote a culture of quality ownership and data integrity.

Desired Qualifications

  • Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or related discipline.
  • 7 to 10 years of QA or QC experience in a regulated environment.
  • Strong expertise in analytical chemistry including HPLC, UPLC, GC, KF, UV-Vis, and FTIR.
  • Experience with batch release, product disposition, and QA data review.
  • 3 to 5 years of leadership experience.
  • Strong experience with investigations, CAPA, and data integrity.
  • Experience supporting FDA inspections and client audits.
  • Excellent technical writing and documentation review skills.
  • Strong scientific judgment and ability to manage competing priorities.

How to Apply

For immediate consideration, please send your resume to:

[email protected]

Quality Assurance Reviewer Associate Scientist I (Microbiology)

Quality Assurance Reviewer Associate Scientist I (Microbiology)

The Quality Assurance (QA) Microbiology Associate Scientist I supports Prompt Praxis Laboratories quality assurance program by performing independent review of microbiology testing data generated in a cGMP-regulated laboratory environment. This role focuses on verification-based review of microbiological test records where results are clearly defined, such as pass or fail outcomes, and do not require interpretation of analytical output.

The position ensures that all testing activities, documentation, and reported outcomes are accurate, complete, and compliant with regulatory and internal quality standards. This role is ideal for early-career professionals seeking to build QA experience in a microbiology laboratory setting.

Location: Onsite

About Prompt Praxis Laboratories

Prompt Praxis Laboratories (PPL), founded in 2011, is a women-owned analytical and microbiology lab specializing in rapid testing, analytical development, and comprehensive support services. Leveraging modern technology and automation, PPL delivers accurate, high-quality results for Pharmaceutical, Compounding Pharmacy, and Medical Device clients.

Committed to scientific excellence, data integrity, and operational innovation, PPL provides cost-effective solutions that ensure safe, effective drug products. Join PPL and build a career defined by excellence and impact.

Primary Responsibilities

Quality Assurance Data Review

  • Perform independent review of microbiology testing records for compliance with cGMP requirements and internal procedures.
  • Verify completeness and accuracy of test documentation, including environmental monitoring results, bioburden, endotoxin, sterility test records, growth promotion, and media qualification.
  • Confirm that results are recorded and aligned with applicable acceptance criteria, including pass and fail outcomes.
  • Ensure all required documentation, including worksheets, logs, and forms, is complete and GMP compliant.
  • Verify that testing is performed in accordance with SOPs, methods, and specifications.
  • Ensure deviations, OOS, or atypical results are properly documented and escalated as necessary.

Data Integrity and Regulatory Compliance

  • Ensure laboratory documentation complies with cGMP and ALCOA+ data integrity principles.
  • Verify audit trail awareness where applicable.
  • Escalate discrepancies or documentation gaps identified during documentation review.
  • Support audit and inspection readiness as a subject matter expert.

Collaboration and Continuous Improvement

  • Work closely with QC Microbiology and QA teams to resolve documentation issues.
  • Communicate findings clearly and constructively.
  • Support continuous improvement of microbiology QA review processes.
  • Contribute to maintaining a strong culture of quality and compliance.

Desired Qualifications

  • Bachelor's degree in Microbiology, Biology, or a related life science.
  • 2 years of experience in a microbiology or cGMP laboratory environment.
  • Basic understanding of microbiological testing methods.
  • Familiarity with cGMP and documentation practices preferred.
  • Strong attention to detail and organizational skills.
  • Effective communication skills.
  • Ability to follow structured processes with consistency.

How to Apply

For immediate consideration, please send your resume to:

[email protected]

Quality Assurance Group Leader (Stability Studies and R&D)

Quality Assurance Group Leader (Stability Studies and R&D)

The QA Group Leader - R&D and Stability Data Review is responsible for leading a team of QA professionals responsible for the review, verification, and approval of analytical data supporting R&D, method development, validation, and stability studies. This role ensures that all reported data is scientifically sound, compliant, and inspection-ready, with a strong emphasis on data integrity, technical accuracy, and regulatory defensibility.

The Group Leader serves as a critical bridge between Analytical Development and Quality Assurance, ensuring that complex scientific data is appropriately interpreted, documented, and released. The ideal candidate combines strong scientific expertise in Chemistry or Microbiology with quality assurance leadership experience and has demonstrated success managing teams responsible for data review, technical documentation, and regulatory compliance.

Hours / Location: Full Time, Onsite

About Prompt Praxis Laboratories

Prompt Praxis Laboratories (PPL), founded in 2011, is a women-owned analytical and microbiology lab specializing in rapid testing, analytical development, and comprehensive support services. Leveraging modern technology and automation, PPL delivers accurate, high-quality results for Pharmaceutical, Compounding Pharmacy, and Medical Device clients.

Committed to scientific excellence, data integrity, and operational innovation, PPL provides cost-effective solutions that ensure safe, effective drug products. PPL offers a competitive total rewards package, including 401(k) matching, comprehensive employee benefits, and a commitment to ongoing professional development. Join PPL and build a career defined by excellence and impact.

Core Competencies

Data Review and Scientific Interpretation; cGMP Compliance and Data Integrity; Analytical Methods and Stability Study Programs; Technical Writing and Documentation Excellence; Team Leadership and Performance Management; Cross-Functional Collaboration; Audit Readiness and Inspection Support

Primary Responsibilities

Lead Data Review Excellence

  • Review and approve analytical data packages supporting R&D, validation, and stability studies.
  • Ensure data is accurate, complete, traceable, and scientifically sound prior to release.
  • Apply strong scientific judgment to assess method performance, data trends, and result validity.
  • Identify and escalate data inconsistencies, atypical results, or compliance risks.

Leadership Through Expertise

  • Serve as a technical QA leader and escalation point for complex data review questions.
  • Provide real-time coaching and guidance to analysts and reviewers.
  • Influence quality standards through credibility, consistency, and strong decision-making.
  • Coordinate daily workflow across QA reviewers to ensure timely and high-quality output.
  • Mentor and develop team members, improving review consistency and technical capability.
  • Support performance management, training, and development efforts in partnership with QA leadership.

Ensure Data Integrity and Compliance

  • Ensure all documentation meets cGMP, FDA, and ICH requirements.
  • Review analytical reports, stability summaries, and technical documents for clarity and regulatory defensibility.
  • Prevent release of data that does not meet quality or compliance standards.
  • Partner with Investigations on OOS, OOT, or data-related deviations when required.

Partner with Science and Operations

  • Collaborate with Analytical Development, QC, and Stability teams to ensure alignment on data expectations and interpretation.
  • Provide QA input on method validation, stability trends, and study outcomes.
  • Ensure that QA review reflects real-world laboratory execution and scientific context.

Drive Continuous Improvement

  • Identify trends in data review errors, documentation gaps, or inefficiencies.
  • Improve QA processes, templates, and workflows to enhance quality and throughput.
  • Support training initiatives that strengthen data integrity and scientific review capability.

Support Audit and Inspection Readiness

  • Ensure all reviewed data is inspection-ready and defensible.
  • Participate in internal audits, client audits, and regulatory inspections.
  • Clearly articulate QA decisions and scientific rationale when required.

Desired Qualifications

  • Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or a related field. Advanced degree preferred.
  • 5 to 10 years of experience in a cGMP laboratory environment in QA or QC.
  • Strong experience reviewing analytical data, stability studies, or method validation work.
  • Solid understanding of cGMPs, FDA regulations, ICH guidelines, and data integrity principles.
  • Strong technical writing and documentation review skills.
  • Demonstrated ability to mentor, guide, or lead others, formally or informally.

How to Apply

For immediate consideration, please send your resume to:

[email protected]

Interested in Future Opportunities?

We welcome inquiries beyond our current openings. If you do not see a position that matches your experience at this time, you are still encouraged to submit your resume for future consideration.

Please email your resume and cover letter to [email protected] .  All submissions will be kept on file for future opportunities.

 

How to Apply for Open Positions

To apply for any current openings, please send your resume and cover letter to [email protected] .

In the subject line, clearly state the position you are applying for (for example: Application for Laboratory Technician). This helps to make sure that your application is routed correctly.

Copy link
CopyCopied
Powered by Social Snap