Piper Companies is currently looking for an experienced QA Clinical Supplies Specialist in West Point, PA to work for an innovative and growing pharmaceutical manufacturer.

QUALIFICATIONS FOR THE QA CLINICAL SUPPLIES SPECIALIST:

• 2+ years of relevant experience in pharmaceutical/biotech industry or supply chain
• 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

• Electronic batch record review of finished clinical goods to ensure clinical supplies are incompliance with cGMP and SOPs
• Check 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.