Job Description
About the position Piper Companies is currently looking for an experienced QA Clinical Supplies Specialist in Rahway, NJ to work for an innovative and growing pharmaceutical manufacturer. The role involves ensuring that clinical supplies are compliant with current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs). Responsibilities • 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. Requirements • 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 Benefits • Medical • Dental • Vision • 401K • PTO • Sick Leave as required by law • Holidays Apply tot his job