QA Clinical Supplies Specialist

• 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.

• 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

• Strong understanding of SAP, Trackwise, Midas, Veeva, and QMAS is preferred
• Bachelor’s degree in related field preferred

Medical, Dental, Vision, 401K, PTO