Senior QA Associate
About The Position
Penn Life Sciences is seeking a Senior QA Associate to join our team in Langhorne, PA. The Senior QA Associate will ensure the quality, accuracy, and compliance of documentation, records, and data generated within sterile injectable manufacturing operations. This position plays a critical role in supporting batch release readiness, data integrity, and adherence to regulatory requirements including 21 CFR Parts 210/211, Part 11, ICH Q10, USP, and EU Annex 1. The ideal candidate will bring strong experience reviewing laboratory and manufacturing data, supporting investigations, and providing on-the-floor QA oversight within classified aseptic areas.
Requirements
- Bachelor's degree in Biology, Chemistry, Microbiology, Pharmaceutical Sciences, or a related life-science discipline.
- 4-8 years of GMP experience in sterile injectables, aseptic manufacturing, QC microbiology/chemistry, or pharmaceutical QA roles.
- Proven experience performing detailed data review of laboratory, batch record, EM, and equipment documentation.
- Strong understanding of aseptic technique, gowning classifications, contamination control, and cleanroom operations.
- Advanced knowledge of cGMP regulations, FDA and EU requirements, and ALCOA+ data integrity standards.
- Excellent communication and documentation skills with the ability to provide clear QA feedback.
- Proficiency in Microsoft Office and GMP electronic systems (LIMS, EDMS, or QMS).
Responsibilities
- Review and approve GMP documentation, including batch records, logbooks, and laboratory data for completeness, accuracy, and compliance with ALCOA+ principles.
- Perform data review for laboratory and environmental monitoring results to support batch disposition and quality decisions.
- Provide QA presence on the manufacturing floor and within classified areas to verify aseptic technique, gowning compliance, and adherence to documentation practices.
- Support deviations, OOS/OOT investigations, and change controls through independent QA review and data verification.
- Evaluate component, equipment, and utility readiness for manufacturing use and review associated qualification documentation.
- Participate in quality improvement initiatives and contribute to SOP and documentation enhancements to strengthen data integrity and compliance.
Benefits
- 401(k) with company match
- Health, vision, and dental Insurance
- Childcare expense reimbursement
- Tuition reimbursement
- Annual bonus eligibility
- Annual merit increases
- Paid Time Off and Flexible Holidays
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
11-50 employees
