Senior QC Specialist
Accentuate Staffing is partnering with a leading CDMO in efforts to find a Senior QC Specialist to join their team. This is a contract opportunity, offering competitive pay while workng onsite. The ideal candidate has a Bachelor’ degree and 5+ years of QC/QA experience in a GMP-regulated, laboratory environment. This person will have extensive experience performing QC Data Review and Laboratory Investigations.
Responsibilities:
- Oversight for review of QC and Stability data for compliance with Customer Requirements and specifications and regulatory requirements.
- Author or act as reviewer for lab investigations, deviations, protocols and specifications for raw materials and finished products.
- Schedule the QC laboratory workload appropriately to meet customer release testing schedules, stability pull dates and timelines.
- Monitor weekly laboratory and data review activities for accuracy and track hours needed for completion of tasks.
- Interact with third party laboratories for microbial and analytical testing of finished products and raw materials.
- Generate and/or review shipping paperwork for third part testing and prepare samples for shipment.
Requirements:
- B.S. in a scientific discipline combined with 5+ years of experience in a Quality Control/Assurance role within the pharmaceutical industry.
- Experience with USP, EP and JP monographs.
- Experience lab applications such as Empower CDS, (UV Spectral, Ion detectors), FTIR, and Particle size Mastersizer.
- Experience with Power BI is a plus
- Experience performing Data Review of Analytical data and Laboratory Investigations per GDP guidelines.
- Proven ability to review and evaluate the compliance and completeness of analytical data.
