QA Clinical Supplies Specialist

Responsibilities

• Electronic batch record review of finished clinical goods to ensure clinical supplies are compliant with cGMP and SOPs
• Clinical supplier specifications, labeling, storage, etc.
• Review of Electronic records for regulatory submissions (IND or CTA)

Qualifications

• 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 and Benefits

Salary Range: $35 - $40/hr
Comprehensive Benefits: Medical, Dental, Vision, 401K, PTO, Sick Leave as required by law, and Holidays