| Location | Morrisville, North Carolina |
QA Specialist (Biotech) needs 3 years of experience in the biotech/pharmaceutical industry within research and development or commercial organizations.
QA Specialist (Biotech) requires:
o Pharma, Biotech industry
o Veeva
o cGMP manufacturing environment
o FDA
o Kneat
o Slinshot
o SAP
o Blue mountain RAM
o Knowledge of manufacturing, batch record review, and/or analytical analyses for the biotech/pharmaceutical
o Degree in Chemistry, biological or other
QA Specialist (Biotech) duties:
o Responsible for performing inspection and disposition of raw materials and components by:
o Supporting incoming material release activities within the ERP system, ensuring compliance with applicable regulations and internal procedures.
o Get Certificates of Analysis (CoA), Certificates of Compliance (CoC), and other required documentation from vendors in alignment with the Master Specification
o 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.
o 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.