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. ·
Numbers & Facts
Location
Atlanta, Georgia
Skills
Analysis Skillsunmatched
Biotech and Pharmaceuticalunmatched
Chemistryunmatched
Clinical Researchunmatched
Corporate Policiesunmatched
Current Good Manufacturing Practice (cGMP)unmatched
Documentationunmatched
ERP (Enterprise Resource Planning)unmatched
FDA (Food and Drug Administration)unmatched
Maintain Complianceunmatched
Manufacturingunmatched
Quality Assuranceunmatched
Regulatory Complianceunmatched
Research & Development (R&D)unmatched
SAPunmatched
Time Managementunmatched
Warehousingunmatched
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