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Biotech QA Specialist

Job in Morrisville, Wake County, North Carolina, 27560, USA
Listing for: Globalchannelmanagement
Full Time position
Listed on 2026-01-12
Job specializations:
  • Quality Assurance - QA/QC
    QA Specialist / Manager, Quality Control / Manager, Quality Technician/ Inspector
Salary/Wage Range or Industry Benchmark: 60000 - 80000 USD Yearly USD 60000.00 80000.00 YEAR
Job Description & How to Apply Below

Job Description

Requirements
  • 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
Duties
  • Responsible for performing inspection and disposition of raw materials and components by :
  • li>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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