QC Associate Biochemist
B.S. degree in a science field required
Willing to work on call and able to respond with 60 min
A maximum of 36 months experience- given that this position is entry level.
- Ability to work both individually and as part of a team with very good communication skills (verbal and written).
- Strong organizational skills.
- Ability to learn new methods and analyze data, including trends.
The Associate Biochemist performs stability sampling, testing, and data review for biopharmaceutical drug substance and drug products (clinical and commercial).
- Performs stability inventory management, which includes sample coordination, aliquoting for routine testing, coordinating sample shipments, performing sample inspections, performing aseptic bulk stability fills, and performing annual inventory inspections.
- Performs routine compendial testing on stability samples per SOP and GMP (visual inspection, pH, osmolality, residual moisture, subvisible particulate matter, container closure integrity).
- Performs laboratory duties following all safety, cGMP, CFR and other regulations in order to assure laboratory compliance.
- Performs routine laboratory duties and safety checks to ensure compliance, as assigned.
- Performs stability data verification for use in stability reports, and responsible for updating stability data tables and trends, as required.
- Utilizes LIMS in daily laboratory and stability operations.
- Operates and maintains QC laboratory equipment/instrument per GMP, including responsibilities for installing / deactivating equipment/ instrument per GMP procedures, as assigned.
- Participates in the on-call response team for chamber excursions, as assigned.
- Assists in compendia methods and other analytical method qualification/validation/transfer as assigned. Writes protocols and reports as assigned.
You may apply for this position online by selecting the Apply now button.
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