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. ·