QA Specialist (Biotech)
Posted Updated
Summary
On-site QA Specialist in Atlanta for a biotech/pharmaceutical operation: inspects and dispositions raw materials, obtains CoA/CoC documentation from vendors, and reviews and approves manufacturing batch records in a cGMP environment. Core tools include Veeva, Kneat, Slingshot, SAP, and Blue Mountain RAM; requires 3 years of biotech/pharma experience and a degree in Chemistry or a biological field.
QA Specialist (Biotech) needs 3 years of experience in the biotech/pharmaceutical industry within research and development or commercial organizations.
QA Specialist (Biotech) requires:
- 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
- Degree in Chemistry, biological or other
QA Specialist (Biotech) duties:
- 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. ·