QA Clinical Supplies Specialist (Hybrid Schedule)

Piper Companies is currently looking for an experienced QA Clinical Supplies Specialist in Rahway, NJ 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:

• Pay Rate: $35-40 Per Hour

• 1 Year Contract with possible extension

• Comprehensive benefit package; Cigna Medical, Cigna Dental, Vision, 401k w/ ADP

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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