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Biotech QA Specialist
Job in
Morrisville, Wake County, North Carolina, 27560, USA
Listed on 2026-02-08
Listing for:
Globalchannelmanagement
Full Time
position Listed on 2026-02-08
Job specializations:
-
Quality Assurance - QA/QC
QA Specialist / Manager, Quality Control / Manager -
Pharmaceutical
Job Description & How to Apply Below
Overview
QA Specialist (Biotech) needs 3 years of experience in the biotech/pharmaceutical industry within research and development or commercial organizations.
Qualifications- Pharma, Biotech industry
- Veeva
- cGMP manufacturing environment
- FDA
- Kneat
- Slinshot
- SAP
- Blue Mountain RAM
- Knowledge of manufacturing, batch record review, and/or analytical analyses for the biotech/pharmaceutical industry
- Degree in Chemistry, biology or other
- Responsible for performing inspection and disposition of raw materials and components by:
- Supporting incoming material release activities within the ERP system, ensuring compliance with applicable regulations and internal procedures.
- Get Certificates of Analysis (CoA), Certificates of Compliance (CoC), and other required documentation from vendors in alignment with the Master Specification.
- Conduct thorough reviews of logbooks and Work Orders across Manufacturing, Engineering, Quality, and Warehouse departments to ensure entries are complete, accurate, and compliant with company policies and procedures.
- Responsible for providing QA review/approval of the completed Manufacturing batch records in a timely manner and ensuring that the entries adhere to the company policies and procedures.
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