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Description

Job Description

Position is Swing Shift

Work with the manufacturing department as a production area Quality Assurance representative.
Coordinate and facilitate Quality Assurance related production and production related activities.
Ensure timely issuance of production records, procedures and labels.
Ensure timely assessment and closure of discrepancies, deviations and change controls.
Review batch-related documentation and ensure resolution of issues to release product.
Communicate lot disposition pending issues to management.
Ensure approval and timely delivery of final product .
Ensure products are manufactured in compliance with regulatory and GMP guidelines.
Review and approve manufacturing and validation documents for regulatory and Kite compliance.
Review and approve manufacturing production records.
Compile and verify all batch-related documents into a final product lot disposition package.
Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues.
Review and disposition raw materials, components, and labels for GMP use.
Review equipment and facility technical and investigation reports.
Review and approve proposed changes to systems, procedures, methods, and submissions to regulatory agencies
Gather metric information for use in continuous improvement of areas of responsibility. Report to management as needed.

Requirements

Perform other duties as required.

Bachelor

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