(7 / 21) Senior Quality Control Technician

1 month ago


Durham, United States Baebies Inc Full time
  • The position performs routine and non-routine analytical testing and performs regular data entry and analysis for lot release of in vitro diagnostic products, assays and reagents.
  • Responsible for in line production quality assurance inspections, batch record (device history record) reviews, and product release.
  • Collect and enter data on batch records and into controlled spreadsheets.
  • Perform DHR (device history record) review and lot release.
  • Ensure batch records meet content and compliance requirements.
  • Helps to train new team members and remains available to them as an SME on lab testing and processes.
  • Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, and processes.
  • Carry out special projects like investigation testing, validation activities, and stability monitoring.


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