10/29/14 – QA Specialist

Accentuate Staffing is currently recruiting for a QA Specialist to join our growing client in the development of their QA programs.  This position is located in the RTP area.

Responsibilities

  • Assist in the establishment and ongoing maintenance of QA programs.
  • Perform data entry and record issuance tasks supporting QA programs.
  • Coordinate, assemble, and route documentation to support QA document review and approval of batch records as required by Quality Systems Management policy.
  • Perform authoring, review, and/or verification of item specifications for raw materials and consumables.
  • Conduct inspection and disposition activities for incoming production materials.
  • Perform raw material sampling, submission, and review of test results for disposition of materials.
  • Initiate and provide support for Nonconformance Reports for nonconforming raw materials and consumables.

Requirements

  • Bachelor’s degree in science or engineering and 3 or more years of quality assurance experience in the biotechnology industry or Associate’s degree and more than 5 years of quality assurance experience in the biotechnology industry.
  • Experience with quality programs for biopharmaceutical manufacturing.
  • Experience or capabilities with creating and/or verifying item specifications.
  • Knowledge and experience with raw material testing, release, and batch record review.
  • The employee is occasionally required to stand, up to 6 hours a day; walk; reach with hands and arm and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 40 pounds.
  • Proficiency with MS Office applications required.