QA Clinical Supplies
1 week ago
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
• Check c linical 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 for the QA Clinical Supplies Specialist:
• 2 + years of relevant experience in pharmaceutical/biotech industry or supply chain
• 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 for the QA Clinical Supplies Specialist:
- S alary Range: $38 - $46/hr
- Comprehensive Benefits: Medical, Dental, Vision, 401K, PTO, Sick Leave as required by law, and Holidays
This job opens for applications on 12/17/2024. Applications for this job will be accepted for at least 30 days from the posting date.
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
#LI-NW1 #LI-ONSITE
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