Manufactures products and completes associated documentation. Contributes to the transfer of new products into Manufacturing.
- Manufactures products and complete batch records following cGMPs. Products include reagents, calibrators, buffers, controls, etc.
- Weighing, transfer, mixing of chemicals required.
- Perform filtration and functional testing of these products.
- Reviews and approves completed batch records.
- Maintains and analyzes lot histories for trends and discrepancies.
- Trains other chemists on equipment and procedures.
- May write, review, and modify SOPs, work instructions and reports.
- Maintains, troubleshoots and validates equipment as appropriate.
- Keeps department lead or manager updated on all issues.
- Performs other job duties as required.
- BS/BA in scientific discipline (chemistry/biochemistry) with 0-3 years 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:
- The 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.