What are the responsibilities and job description for the QA Clinical Supplies Specialist position at Piper Companies?
Piper Companies is looking for an experienced QA Clinical Supplies Specialist in West Point, PA to work for an innovative and growing pharmaceutical manufacturer.
Onsite 3x per week.
Responsibilities for the QA Clinical Supplies Specialist:
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 $30-
Onsite 3x per week.
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.
- 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
- $23-$27/hr
- 1 Year Contract with possible extension
- Comprehensive Benefits: Medical, Dental, Vision, 401K, Sick Leave if required by law
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 $30-
Salary : $23 - $27