QA Specialist, Clinical Finished Goods

Piper Companies is currently seeking a QA Specialist, Clinical Finished Goods for a hybrid-based opportunity in Rahway, New Jersey (NJ), to join a multinational pharmaceutical manufacturer bringing forward life-saving medications and vaccines.

Responsibilities of the QA Specialist, Clinical Finished Goods

• 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 of the QA Specialist, Clinical Finished Goods

• 2-5 years of quality assurance or clinical development experience in a GMP environment
• Experience within biologics and/or vaccines is preferred
• Strong understanding of SAP, Trackwise, Midas, Veeva, and QMAS is preferred
• Bachelor's Degree in life science related field required

Compensation for the QA Specialist, Clinical Finished Goods

• Salary Range : $32.00 - $38.00 / hour
• Benefits : Medical, Dental, Vision, 401k match, Paid Holidays, and PTO
• Long Term Contract Opportunity
• Hybrid Onsite / Work From Home Schedule

Keywords: pharmaceutical, pharma, clinical supplies, regulatory review, batch record review, batch disposition, GMP, cGMP, current good manufacturing process, good manufacturing process, QA, quality assurance, clinical development, clinical quality, vaccines, biologics, electronic batch record, SOPs, specification, labeling, SAP, trackwise, midas, veeva, QMAS

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