Manufactures products and completes associated documentation. Contributes to the transfer of new products into Manufacturing. Participates in process improvement projects.
- Manufacture products such as reagents, calibrators, buffers, and controls and complete batch records following cGMPs.
- Review and approve completed batch records.
- Perform in-process assays using clinical analyzers. Review and analyze data.
- Will weigh, transfer, and mix chemicals
- Perform product filtrations.
- Maintain and analyze lot histories for trends and discrepancies.
- May train other chemists on equipment and procedures.
- May write, review, and modify SOPs, work instructions and reports.
- Maintain, troubleshoot and validate equipment as appropriate.
- Execute process validations as appropriate.
- Keep department lead or manager updated on all issues.
- Monitor stocks of common lab supplies.
- Perform other job duties as required.
- BS/BA in scientific discipline (biology/biochemistry) with 0-2 years of related experience and/or training preferred. AA degree with 2-4 years related experience may be substituted.
- Basic lab skills and knowledge of safety precautions.
- Familiarity with Quality System Regulations.
- Experienced working with potentially hazardous chemicals and human source materials.
- Must be able to lift 25 lbs routinely.
- May be required to lift up to 50 lbs occasionally.
Non-Negotiable Hiring Criteria:
- This position does not offer relocation assistance
- Must be in compliance with GMP, QSRs, ISO and IVD regulations in the performance of department responsibilities.
- Strong laboratory skills including pipetting, safety, and hazardous chemical handling.
- Must be organized and detail oriented to be able to prioritize own and other’s work and meet business productivity metrics.
- Self sufficient, self-motivated, and focused.