QA Clinical Supplies

Piper Companiesis currently looking for an experiencedQA Clinical Supplies SpecialistinWest Point, PAto 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

· 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.

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 with in 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:

·$38-43hr

· 1-year contract with possible extension

· Medical, Dental, Vision, 401K, PTO

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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