About Prompt Praxis Laboratories

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.

Primary Responsibilities

Physical and Particulate Testing Execution

• Perform routine and advanced physical testing including appearance, pH, osmolality, visual inspection, and gravimetric measurements in accordance with approved SOPs, specifications, and cGMP requirements.
• Execute particle sizing and particle identification testing using USP <788> and <789> Method I (light obscuration) and Method II (microscopy), as applicable.
• Support testing of raw materials, excipients, APIs, finished products, compounded preparations, and stability samples.
• Prepare samples, standards, controls, and solutions with attention to accuracy, traceability, and material conservation.
• Analyze, trend, and interpret test results; identify atypical results and escalate per established 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 (ALCOA+), and PPL quality systems.
• Support investigations including OOS, deviations, excursions, and CAPAs related to physical and particulate testing.
• Participate in method verification, validation, transfer, and robustness studies as assigned.
• Contribute to SOP creation, review, and continuous improvement initiatives related to physical and particulate testing.

Equipment, Instrumentation, and Laboratory Readiness

• Operate, maintain, and troubleshoot physical testing instrumentation including pH meters, osmometers, analytical balances, visual inspection systems, particle counters, and microscopy systems.
• Perform routine equipment checks, calibrations, and maintenance in accordance with SOPs and metrology requirements.
• Support laboratory organization, materials management, and readiness for audits and inspections.
• Ensure proper handling, labeling, storage, and disposal of samples and materials.

Collaboration and Continuous Improvement

• Work closely with Physicals 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.
• Participate in training and mentoring of junior staff, as appropriate.

Desired Qualifications

• BA or BS in Pharmaceutical Sciences, Biochemistry, or a related scientific discipline.
• Four or more years of experience in a cGMP-regulated analytical laboratory with direct experience in physicals and particulate testing.
• Hands-on experience performing appearance, pH, osmolality, and gravimetric testing.
• Demonstrated experience with particle sizing using Method I (light obscuration) and Method II (microscopy).
• Strong understanding of USP <788>, <789>, and applicable compendial and regulatory requirements.
• Working knowledge 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 including Word, Excel, and Outlook.
• 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]

About Prompt Praxis Laboratories

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.

Primary Responsibilities

Sample Receiving, Handling, and Tracking

• Receive incoming client samples and internal materials, ensuring accurate log-in, labeling verification, and documentation per approved SOPs.
• Inspect samples upon receipt for integrity, proper packaging, and labeling accuracy; escalate discrepancies according to established procedures.
• Maintain strict chain-of-custody and location accuracy for all samples throughout receiving, storage, transport, testing, retention, and disposal.
• Ensure proper segregation of samples by status, including received, quarantined, in testing, on-hold, completed, retained, and 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 a clean and compliant condition; perform basic inspections and report maintenance needs.
• Adhere to all safety, DOT, and company driving policies.

Inventory and 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, and 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 or operations experience preferred.
• Prior experience in logistics, warehouse operations, laboratory support, healthcare, or regulated environments preferred.
• Valid driver's license with a 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]