QA and QC Specialist

Eurofins•Sanford, NC
•Onsite

About The Position

The QA and QC Specialist provides Quality Assurance oversight of Quality Control activities. The role reviews and approves QC method validation, equipment qualification, protocols, reports, process control documents, and new and existing procedures. It also supports the evaluation and resolution of QC deviations and investigations and contributes to process improvement initiatives. The position is full-time, Monday through Friday, 8 a.m. to 5 p.m., with overtime as needed. The site is in Sanford, North Carolina, is not accessible by public transportation, and requires reliable daily transportation.

Requirements

  • Bachelor of Science or Bachelor of Arts degree in a scientific or related field.
  • At least 4 years of experience in manufacturing, laboratory, quality, technical, or engineering work within the biotechnology or pharmaceutical industry.
  • GMP experience.
  • Direct experience with method transfer validation, investigations, authoring change controls, and equipment qualification.
  • Experience with testing and executing assays such as HPLC, GC, and raw materials testing.
  • Ability to understand and drive process improvements.
  • Authorization to work in the United States indefinitely without restriction.
  • Reliable daily transportation to and from the site; the site is not accessible by public transportation.

Nice To Haves

  • Pharmacopoeia experience preferred.

Responsibilities

  • Provide Quality Assurance oversight of Quality Control activities.
  • Review and approve QC method validation, equipment qualification, protocols, reports, process control documents, and 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 insurance options
  • Vision insurance options
  • Life insurance
  • Disability insurance
  • 401(k) with company match
  • Paid vacation
  • Paid holidays
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