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QC Investigations, Cell Therapy
Posted on 7/21/2022
Devens, MA, USA
Experience Level
Desired Skills
  • Strong background and demonstrated effectiveness in laboratory or biomanufacturing investigations and root cause analysis techniques
  • Knowledge of cell therapy analytical and microbiological testing is highly desirable
  • Knowledge of US and EU cGMP regulations and health authority inspections
  • Demonstrated interpersonal, written and verbal communication skills
  • Advanced ability to communicate effectively with peers, department management and cross-functional peers
  • Action-oriented and skilled in decision-making, problem solving, planning and organizing
  • Bachelor's degree in science, engineering, or related discipline. Advanced degree preferred
  • 6+ years of experience in biopharmaceutical or QC lab operations with 2+ years of prior investigation experience required. An equivalent combination of education and experience may substitute
  • Subject matter expert leading QC high impact deviations, laboratory investigations, and CAPAs. Author reports for QC deviations, investigations and CAPAs
  • Work with QC method SMEs to conduct root cause analysis. Ensure timely and compliant closure of investigations, deviations and CAPAs
  • Support creation and review of site and department SOPs related to investigations
  • Collaborate with cross functional areas to develop training curricula related to investigations and provide training to new lead investigators
  • Contribute to and support the site team which prepares for, hosts and responds to regulatory inspections, reviews and approvals of the facility and products
  • Apply critical thinking skills during the investigations and process improvements
  • Communicate effectively with management and cross functional teams such as Manufacturing, QC Operations and QA. Present investigation findings at Quality governance forums
Bristol-Myers Squibb

10,001+ employees

Biopharmaceutical development company
Company mission
Bristol-Myers Squibb engages in the discovery, development, licensing, manufacturing, marketing, distribution and sale of pharmaceuticals.