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QC Data Reviewer

POSITION SUMMARY 

The Quality Control Data Reviewer is responsible for reviewing the completeness, accuracy and cGMP compliance of the data and documentation generated in the Quality Control laboratory.  The incumbent to this position must have a strong knowledge of analytical testing in a cGMP pharmaceutical laboratory, good interpersonal skills to have positive constructive interactions with the laboratory staff and management.

KEY RESPONSIBILITIES

  • Review data to ensure accuracy and completeness of testing documentation, including calculations
  • Review calibration and usage logs on cGMP instrumentation and equipment
  • Review audit trails on computer systems used to acquire and process data from instrumentation
  • Ensure compliance of testing with procedures and test methods
  • Work with analysts to correct any errors and omissions in documentation

QUALITIFICATIONS

  • Working knowledge of pharmaceutical analysis including but not limited to: HPLC, GC, FTIR, TOC, KF, and various wet chemistry techniques. 
  • Willingness and ability to focus on review of data related to raw materials, in-process testing, finished product testing, and other laboratory documentation, working toward real-time review of data
  • B.S. degree in chemistry or similar discipline
  • 3-5 years of experience in pharmaceutical analysis and review of cGMP analytical data
  • Preference will be given to someone having worked in a fast-paced quality control environment
  • Strong experience with Good Documentation Practices
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