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QA Specialist - III

San Mateo, CA 94404

Posted: 11/11/2022 Employment Type: Contract Job Category: Quality and Compliance Job Number: 505808 Country: United States Is job remote?: No

Job Description

Responsibilities include:
Pay Rate Range: $48-55/hr
  • Provide Quality Assurance (QA) oversight of the manufacturing operation at our commercial manufacturing site in Frederick, Maryland.
  • Perform review and Quality approval of Manufacturing, Quality Control and Facilities deviations, GMP and Quality system issues, non-conformances and corrective actions (CAPAs).
  • Represent QA in the deviations review meetings.
  • Manage the day-to-day activities for the initiation, tracking and closure of non-conformances for lot disposition.
  • Provide updates to management for deviations, GMP and system issues and CAPAs.
  • Support QA operations on the floor.

Skills/Qualifications: Bachelors degree in technical discipline (Biology/Chemistry/Microbiology/Engineering or related field) with a minimum of 5-7 years of experience in Quality Assurance or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility. Must be proficient in Quality Systems, particularly associated with Operations, Lot Disposition, Change Control and Exception Management/CAPA. Working knowledge of quality systems and ability to apply GMP's in conformance to U.S. and EU standards. Strong knowledge of GMP, SOPs and quality systems. Strong interpersonal, verbal and written communication skills. Experience with laboratory and process investigations, deviations, and CAPA.
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