Quality Control - Biochemist
B.S/B.A in Chemistry, Biochemistry, Immunology, Molecular Biology or other science field
High volume of testing, requires a new hire to train fast and work with little supervision during testing.
Proficient in analytical instrument and methods, such as HPLC, spectrophotometer, Capillary electrophoresis, etc
Advanced knowledge in cGMP, CFR and other regulations in order to assure laboratory compliance.
Job Description Summary-
The Biochemist performs quality sampling, testing, and data review for in-process biopharmaceutical materials, active biopharmaceutical ingredients and finished bulk drug substance.
Coordinate routine in-process biopharmaceutical materials, bulk biopharmaceutical ingredient, finished biopharmaceutical product and stability sample testing with testing labs.
Conduct, documents and review (as needed) routine compendial, chemistry, immunology and molecular biology analytical testing for in-process, release and stability samples per SOP.
Train new analysts for analytical test methods per training plans as needed.
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. Develop and/or revise laboratory SOPs as required. Must have good technical writing skills and high attention to detail.
Use QLIMS and SAP as a tool to track laboratory reagents, samples, testing data. Trend analytical results as needed.
Lead in investigation and assay trouble shooting. Advanced knowledge of analytical instrumentation and methods with strong technical and interpersonal skills (ability to work in a team environment).
Lead in compendia methods and other analytical method qualification/validation/transfer. Write and/or review protocols and reports.
Compile reports and trend assay data.
Trained as an L1 Auditor and participate in >25% of department's L1 Inspections.
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