Description :
High Importance Candidates strongly experience with GMPs.
This role supports the daily operations of the QC Raw Materials department, whose primary responsibility is the testing and release of raw materials for GMP use in manufacturing.
In this role, the primary responsibility for the individual in this position is to perform routine analytical testing on raw materials, such as using methods derived from a broad range of compendial and non-compendial analytical techniques as well as peer review of test data.
In addition, the individual may be assigned complex projects such as instrument qualification, method validations, and continuous improvement initiatives with some supervision.
This position is also expected to work with QA and area management on quality systems such as deviations, change controls, CAPAs, and OOS investigations, to achieve timely closure and ensure compliance.
of Time Job duty and Description
- 45 Testing of raw materials per compendial and non-compendial methods for cGMP manufacturing use.
- 10 Support warehouse operations (may include inspection, labeling, and sampling as required).
- 15 Peer review / approval of test data.
- 15 Author / manage planned and unplanned deviations, investigations, change controls, CAPAs, and OOS investigations.
- 15 Project management new instrument / equipment implementation, SOP creation / revision, validation protocol generation / execution, operational excellence / continuous improvement projects.
Essential :
B.S. in Chemistry / Biochemistry / Biology with 2 to 4 years relevant experience.
Desired : Previous experience in a GMP QC role is preferred.
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