Summary
A cutting-edge pharmaceutical company in the Bay Area is looking for a Senior Specialist to join their QC Operations team. The company is engaged in the development of a proprietary technology platform that enables specific regulation of gene expression and gene modification. The Sr. QC Operations Specialist will oversee the QC Sample Management system.
Responsibilities
- Work with QC lab managers on shipping and transfer of GMP test samples, reserve samples, and retain samples
- Draft and review of QC-sample management/materials documents (SOPs, Protocols, Reports etc).
- Oversee the execution of sample handling investigations (missing samples, temperature excursions, etc).
- Assist QC management during all inspections and regulatory audits with emphasis on sample and retain/reserve management.
Qualifications
- Bachelor's Degree
- 5+ years of Quality Control experience
- 3+ years of QC sample management experience
- Understanding of current GMP guidelines