Quality Control Analyst

Job Description:

This role supports the Quality Control, Environmental Monitoring team in maintaining the cleanrooms for commercial manufacturing and environmental monitoring performance qualifications. This role will also be central in all processes associated with environmental monitoring and integral with environmental investigations, excursion report writing, and general upkeep of the micro department. Please note that we are unable to sponsor applicants requiring work authorization or visas for the positions currently available. We kindly request that only candidates who already possess the legal right to work in the United States apply for consideration.

Responsibilities:

• Performance of environmental monitoring. Level 3 gowning qualification is required. There will be events where many hours within the cleanroom at level 3 gowning is required. Work hours may vary dependent on the demands of monitoring.

• Assist with the maintenance of laboratory/ media supplies and equipment.

• Supports investigations for environmental excursions; assist and revise standard operational procedures, trend reports, deviations, and corrective actions.

• Performs other duties as assigned.

• Performs water sampling and gas testing.

• Execute aseptic process validations, EM performance qualifications, and gowning qualifications.

• Inspect aseptic process qualification units.

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