QA and QC Specialist

Eurofins USA PSS Insourcing SolutionsSanford, NC
Onsite

About The Position

Responsible for providing Quality Assurance (QA) oversight of Quality Control (QC) activities. QA review and approval of QC method validation, equipment qualification, protocols, reports, process control documents, and both new and existing procedures. Support the evaluation and resolution of QC deviations and investigations, and contribute to the implementation of process improvement initiatives.

Requirements

  • BS or BA degree Scientist or related field
  • Minimum of 4 years of experience in manufacturing, laboratory, quality, technical or engineering experience within biotech or the pharmaceutical industry
  • GMP Experience required
  • Direct experience with Method Transfer Validation
  • Direct experience with Investigation
  • Direct experience with Authoring Change Controls
  • Direct experience with Equipment Qualification
  • Experience with testing and execution of assays such as HPLC, GC, raw materials testing
  • Ability to understand and drive process improvements
  • Authorization to work in the United States indefinitely without restriction

Nice To Haves

  • Pharmacopia experience preferred

Responsibilities

  • Providing Quality Assurance (QA) oversight of Quality Control (QC) activities
  • QA review and approval of QC method validation, equipment qualification, protocols, reports, process control documents, and both new and existing procedures
  • Support the evaluation and resolution of QC deviations and investigations
  • Contribute to the implementation of process improvement initiatives

Benefits

  • Comprehensive medical coverage
  • Dental options
  • Vision options
  • Life insurance
  • Disability insurance
  • 401(k) with company match
  • Paid vacation
  • Paid holidays
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