Biotech QA Specialist

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.