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QA Specialist – III

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  • Anywhere

Website US Tech Solutions, Inc.

US Tech Solutions, Inc.

Company : US Tech Solutions, Inc.

Country: United States

Location : Frederick, Maryland

Post: Fri, 09 Sep 2022 03:24:17 GMT

Expires: Fri, 07 Oct 2022 23:59:59 GMT

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—————————— Job Description ——————————

Responsibilities include (but are not limited to):

– 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:

· Bachelor’s 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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