Job Description

POSITION SUMMARY:

Cutting edge Pharmaceutical company is in search of a Quality Assurance Specialist.

·      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.

REQUIREMENTS:

·      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