Senior QC Specialist

Company: Accentuate Staffing
Location: Durham
Posted on: February 9, 2025

Job Description:

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 working 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.

Scroll down to find the complete details of the job offer, including experience required and associated duties and tasks.



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.

Keywords: Accentuate Staffing, Durham , Senior QC Specialist, Other , Durham, North Carolina