Manufactures products and completes associated documentation. Contributes to the transfer of new products into Bulk Manufacturing. Participates in continuous improvement projects.
- Manufacture products and complete batch records following SOPs
- Ensure compliance at all times in accordance with cGMP including GDP
- Products include controls, calibrators, proficiencies and linearity sets.
- Perform in-process assays using clinical analyzers. Review and analyze data.
- Weighing, transfer, mixing of chemicals required.
- Perform product filtrations.
- Review and approve completed batch records.
- 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 needed.
- 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 (chemistry/biochemistry) with 1-4 years related experience and/or training preferred. AA degree with 4-6 years related experience may be substituted.
- Experience with Quality System Regulations and cGMP preferred.
- Experience manufacturing In-Vitro Diagnostic quality control products a plus.
- Detail oriented, organized, self-motivated and focused.
- Basic lab skills and knowledge of safety precautions.
- Must be able to walk and/or stand for extended periods of time.
- Must be able to lift 25 lbs routinely; up to 50 lbs occasionally.