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Quality Assurance Specialist
6 days ago
Our esteemed client, a leading pharmaceutical company known for its continuous growth, is seeking a Quality Assurance Specialist II. In this pivotal role you will be hands on working primarily on quality systems, the reserve sample program and incoming attribute inspections.
What You'll Do:
- Asist in quality operations area, such as batch record and quality control data review, line clearances, AQL inspection, and will be interacting with with cross-functional groups.
- Manage the reserve sample program.
- Coordinate and track closure of the change controls, deviations, quality investigations and CAPAs.
- May support quality operations, as needed (e.g., review executed records such as batch records/ quality control data or equipment qualifications; perform line clearance and product inspection; review other records under supervision such as change control requests, deviations, lab investigations, environmental monitoring excursions, proposed CAPAs).
- Support continuous improvement of quality systems. Author new, revise existing department procedures and/or forms.
Requirements:
- Minimum 4 year’s experience performing quality functions in pharmaceutical and/or biotech related fields.
- Some working knowledge of quality systems cGMP standards applicable to clinical biologics DS and DP.
- Ability to independently analyze and reconcile simple issues.
- BS or equivalent in biology, chemistry or related science or equivalent experience.
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