Piper Companies is currently seeking an experienced QA Clinical Supplies Specialist .
This role involves working for a pharmaceutical manufacturer with innovative and growing operations.
Responsibilities:
- Electronic batch record review of finished clinical goods to ensure compliance 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:
- A minimum of 5 years of relevant experience is strongly preferred.
- A quality mindset with background in GMP record review.
- The ability to work independently and be self-driven.
- Experience within biologics and/or vaccines.
- A strong understanding of SAP, Trackwise, Midas, Veeva, and QMAS is preferred.
- A Bachelor's degree in a related field is preferred.
Compensation:
- Salary range: $35-$40/hour.
- Comprehensive benefits including medical, dental, vision, 401K, PTO, sick leave as required by law, and holidays.