• QC
  • Durham, NC, USA
  • Full Time

Essential Responsibilities
  • Quality Control (QC) technical, scientific and compliance review of data generated by the Bioanalytical Operations group in support of regulated studies (e.g. GLP, GMP)
  • Identify deviations, OOS and OOT associated with Bioanalytical Operations data
  • Issue QC review reports and work closely with the scientific staff to ensure compliance with appropriate regulations
  • Assist in collecting metrics data used to monitor the QC processes
  • Follow QCT SOPs
  • Other duties as needed


Minimum Acceptable Qualifications

  • Bachelor's degree in biological science or related field with > 2 years' experience working in biotech, pharmaceutical, CRO/CMO or similar organization
  • Knowledge of GxP regulations
  • Experience with large molecule bioanalytical methods such as immunoassays and cell-based assays
  • Ability to work in a fast-paced team environment where multiple concurrent projects must be completed in a timely manner
  • Ability to take direction well and multi-task
  • Detail oriented and highly organized
  • Excellent oral and written communication skills
  • Proficient in the use of MS Excel and Word
  • Proficient in the use of LIMS and Quality Management software packages
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