Adaptimmune USA

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Adaptimmune USA
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Quality Control Supervisor

Reference: AUG20170497
Expiry date: 2017-09-22 17:55:27.887
Location: Philadelphia
Benefits: Competitive

RESPONSIBILITIES

  • 50% Sample management (receipt, test scheduling, data review maintenance and reporting)
  • 30% QC Personnel Management (time off scheduling, personnel reviews, personnel issues)
  • 10% Training Program Management
  • 10% Document Control Management (SOPs, Reports, Out of Investigation Reports etc.)

REQUIREMENTS

  • Five years working in a GMP quality control laboratory with three years of management / leadership roles
  • Experience conducting laboratory/deviation investigations and establishment of appropriate CAPAs (if required)
  • Proficient knowledge of GMP regulations including USP and EP testing requirements
  • Experience conducting time critical testing of in-process and finished product to meet clinical trial needs.
  • Familiarity with flow cytometry, ELISA, endotoxin, PCR
  • Ability to prepare data trending reports, and to author, review and maintain test methods, qualification protocols, SOPs and reports
  • Conduct laboratory and deviation investigations and CAPAs as needed
  • Knowledge in personnel reviews/ assessments (preferred)
  • Technical writing skills for drafting equipment and laboratory standard operating procedures