Job Description
Senior QA Associate
About Penn Life Sciences
Penn Life Sciences (PLS) is a rapidly growing pharmaceutical manufacturer dedicated to producing high-quality sterile generic drug products. Headquartered in Langhorne, Pennsylvania, PLS is developing a modern, U.S.-based sterile manufacturing facility designed to meet the highest FDA and global cGMP standards. Our mission is to strengthen domestic pharmaceutical supply, enhance patient access to affordable, life-saving medications, and uphold the values of integrity, innovation, and scientific excellence in everything we do.
What You’ll Do
The Senior QA Associate is responsible for providing advanced Quality Assurance oversight within a sterile injectable manufacturing environment. This role performs detailed GMP data review, supports aseptic operations, and ensures the accuracy, completeness, and compliance of manufacturing, laboratory, and equipment documentation. The Senior QA Associate serves as a QA subject matter expert for sterile operations, component readiness, and data integrity, while supporting investigations, change controls, and inspection readiness activities. This position also provides on-the-floor QA presence to uphold aseptic technique, gowning compliance, and operational excellence across classified cleanroom areas.
Key Responsibilities:
• Review and approve batch records, logbooks, equipment forms, and controlled GMP documentation to ensure accuracy, completeness, and compliance with procedures.
• Perform detailed review of laboratory data (microbiology, chemistry, environmental monitoring, utilities testing, and in-process data) in alignment with ALCOA+ data integrity expectations.
• Provide routine QA presence within classified cleanroom areas (Grades A–D) to verify compliance with aseptic technique, gowning standards, documentation practices, and SOP adherence.
• Conduct walk-throughs of manufacturing, utilities, and support areas to evaluate data integrity, equipment status, sample accountability, and documentation compliance.
• Review and approve SOPs, protocols, qualification documents, and equipment readiness packages to ensure regulatory and internal compliance.
• Support deviations, OOS/OOT events, and change controls through objective data review, fact gathering, and QA assessments while maintaining independence from investigator ownership.
• Assess and verify component, material, and equipment release status prior to use in sterile manufacturing operations.
• Monitor adherence to aseptic behaviors, EM sampling practices, cleaning documentation, and contamination control expectations.
• Collaborate with Manufacturing, QC, Facilities & Engineering, and Validation to ensure timely resolution of quality or documentation issues.
• Support internal and external audits/inspections by preparing documentation, retrieving records, and providing SME-level information on QA oversight and data review processes.
• Participate in quality system improvement initiatives to reduce documentation errors, enhance data governance, and improve right-first-time execution.
• Assist in drafting, revising, and improving SOPs, forms, templates, and workflows to strengthen compliance and data reliability.
• Mentor and provide guidance to junior QA staff on GMP expectations, data integrity, and documentation standards.
• Perform additional duties as assigned to support site quality objectives and inspection readiness.
What We’re Looking For
Experience: 4–8 years of GMP experience in sterile injectables, aseptic manufacturing, QC microbiology/chemistry, or pharmaceutical QA roles. Strong experience in data review and on-the-floor QA oversight in classified areas (Grades A–D) is highly preferred.
Education: Bachelor’s degree in Biology, Chemistry, Microbiology, Pharmaceutical Sciences, or a related scientific discipline required. Skills & Knowledge:
• Advanced knowledge of GMP regulations, 21 CFR Parts 210/211, Part 11, EU Annex 1, USP, and ICH guidelines.
• Strong proficiency in ALCOA+ data integrity principles and their application in manufacturing and laboratory settings.
• Experience reviewing laboratory data (microbiology, chemistry, EM, utilities) for sterile operations.
• Ability to interpret and review batch records, logbooks, and controlled documentation with high attention to detail.
• Strong understanding of aseptic technique, gowning classifications, cleanroom behaviors, and contamination control.
• Experience supporting and reviewing deviations, OOS/OOT investigations, and change controls.
• Excellent written and verbal communication skills for documenting QA assessments and interacting with cross-functional staff.
• Proficiency in Microsoft Office and GMP electronic systems such as LIMS, EDMS, or QMS platforms.
• Strong time-management abilities with the capacity to prioritize work in a fast-paced sterile manufacturing environment.
What We Offer
• Competitive compensation with annual performance bonus eligibility
• Annual merit-based pay increases
• Automatic enrollment in a 401(k) at 3% pre-tax with 50% company match on the first 6% contributed
• Paid Time Off
• 10 paid company holidays
• Comprehensive medical, dental, vision, and life insurance coverage
• Professional development reimbursement
• Career growth opportunities within Quality and Operations
• Tuition reimbursement for children and childcare expense reimbursement
Schedule
Full-time, on-site position with standard business hours ( Monday through Friday; day shift. ).
Company DescriptionPenn Life Sciences (PLS) is a rapidly growing pharmaceutical manufacturer dedicated to producing high-quality sterile generic drug products. Headquartered in Langhorne, Pennsylvania, PLS is developing a modern, U.S.-based sterile manufacturing facility designed to meet the highest FDA and global cGMP standards. Our mission is to strengthen domestic pharmaceutical supply, enhance patient access to affordable, life-saving medications, and uphold the values of integrity, innovation, and scientific excellence in everything we do.
Penn Life Sciences (PLS) is a rapidly growing pharmaceutical manufacturer dedicated to producing high-quality sterile generic drug products. Headquartered in Langhorne, Pennsylvania, PLS is developing a modern, U.S.-based sterile manufacturing facility designed to meet the highest FDA and global cGMP standards. Our mission is to strengthen domestic pharmaceutical supply, enhance patient access to affordable, life-saving medications, and uphold the values of integrity, innovation, and scientific excellence in everything we do.
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