Quality Assurance Specialist

frederick, Maryland

A leading pharma company is seeking a QA specialist. This role is a 3rd shift role - 6pm - 6:30am with 4 days on and 3 days off. 

Responsibilities

  • Oversee/ensure quality of commercial and clinical products being manufactured
  • Implement policies for process improvements
  • Maintain database and generate reports
  • Collect metrics to track performance
  • Batch Production Record and autoclave review
  • Review, assess and approve change controls
  • Perform on the floor inspections of production areas
  • Assist in product changeover, zone promotions, placing QA hold tags, logbook extensions

Qualifications

  • Bachelor's in a Science (e.g. Biology, Chemistry) or Engineering (e.g. Biochemical, Chemical, Mechanical) field - Master's preferred
  • 5+ years of biotech/pharma experience
  • 3+ years of Quality Assurance/Quality Control experience

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