Biotech QA Specialist
Globalchannelmanagement, Morrisville, North Carolina, United States, 27560
Overview
QA Specialist (Biotech) needs 3 years of experience in the biotech/pharmaceutical industry within research and development or commercial organizations.
Qualifications
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 industry
Degree in Chemistry, biology or other
Responsibilities
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.
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Qualifications
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 industry
Degree in Chemistry, biology or other
Responsibilities
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.
#J-18808-Ljbffr