B.S. degree in a science field required
Chemistry, Biochemistry, Immunology, Molecular Biology or other science field
1-4 years experience in QC lab, experience in release and stability testing, SDS-PAGE, HPLC, CE (Capillary Electrophoresis), GMP experience
Advanced knowledge in cGMP, CFR and other regulations in order to assure laboratory compliance.
Job Description Summary-Job Family - Quality Control:
Conducts a wide range of quality control tests and analyses on products to uncover defects. Reports to management who make the decision to allow or deny the release. Testing for process monitoring. Testing of Raw Materials
Job Family Group - Quality:
Develops and implements programs to establish and maintain quality standards of existing products, and internal systems and processes. Develops policies, procedures and methods to check product, material, components and/or operational quality and improve same.
Coordinate routine in-process biopharmaceutical materials, bulk biopharmaceutical ingredient, finished biopharmaceutical product and stability sample testing with testing labs.
Conduct and documents routine compendial, chemistry, immunology and molecular biology analytical testing for in-process, release and stability samples per SOP.
Operate and maintain QC laboratory equipment/instrument in a cGMP-compliant manner.
Evaluate laboratory SOPs and recommend improvement opportunities to maintain compliance with corporate and regulatory guidelines. Develops or revises laboratory SOPs as required.
Assist in investigation and assay trouble shooting.
Assist in compendia methods and other analytical method qualification/validation/transfer. Write protocols and reports as needed.
Meet lab safety requirements.
Trained as an L1 Auditor and participate in >25% of department's L1 Inspections.
You may apply for this position online by selecting the Apply now button.
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