Current Good Manufacturing Practice (cGMP), Drug Manufacturing, GMP (Good Manufacturing Practices), Investigational New Drug (IND), Legal, Medical Products, Quality Assurance, Regulatory Submissions, SAP, Standard Operating Procedures (SOP), Vaccination
Piper Companies is currently looking for an experienced QA Clinical Supplies Specialist in Lansdale, PA to work for an innovative and growing pharmaceutical manufacturer.
Responsibilities for the QA Clinical Supplies Specialist:
- Electronic batch record review of finished clinical goods to ensure clinical supplies are incompliance with cGMP and SOPs
- Clinical supplier specifications, labeling, storage, etc.
- Review of Electronic records for regulatory submissions (IND or CTA)
- Areas of focus will include biologics, vaccines, combination products, etc.
Qualifications for the QA Clinical Supplies Specialist:
- 5+ years of relevant experience is strongly preferred
- Quality mindset with background in GMP record review
- Self-driven, and capable of working independently
- Experience within biologics and/or vaccines
- Strong understanding of SAP, Trackwise, Midas, Veeva, and QMAS is preferred
- Bachelor's degree in related field preferred
Compensation for the QA Clinical Supplies Specialist:
- Salary Range: $35 - $40/hr
- Comprehensive Benefits: Medical, Dental, Vision, 401K, PTO, Sick Leave as required by law, and Holidays
This job opens for applications on 6/29/2026 Applications for this job will be accepted for at least 30 days from the posting date.
Keywords: clinical supplies, biologics, vaccines, electronic batch record review, batch record, cGMP, SOPs, specifications, labeling, regulatory submissions, SAP, Trackwise, Midas, Veeva, QMAS, QA, Quality Assurance
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