QC Scientist - Level 1 US Job Responsibilities
Education & Qualifications
- Coordinate routine in-process bio-pharmaceutical materials, bulk bio-pharmaceutical ingredient, finished bio-pharmaceutical 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.
- Advanced knowledge in cGMP, CFR and other regulations in order to assure laboratory compliance.
- 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 critical reagent qualification/re-qualification, in compendia methods and other analytical method qualification/validation/transfer.
- Meet lab safety requirements.
- Trained as an Self Inspector Auditor and participate in 25% of department's Self Inspections
- B.S. degree in a science field required
- Chemistry, Biochemistry, Immunology, Molecular Biology or other science field
- Some knowledge of analytical instrumentation with technical and interpersonal skills (ability to work in a team environment).
- Ability to follow laboratory testing procedures.
- 2-3 years experience
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.