POSITION SUMMARY:

Manufactures products for the Bulk Formulations Toxicology team and completes associated cGMP documentation. Works with chemicals and biologicals to manufacture reagents, calibrators, and controls for IVD immunoassay use. Participates in projects to drive process improvements.

MINIMUM REQUIREMENTS/QUALIFICATIONS:

• BS/BA in scientific field (Chemistry or Biochemistry preferred) with 0-2 years related experience and/or training preferred. Equivalent combination of education and years of related experience may be substituted.
• Must be able to lift 25 lbs routinely

• Manufacture products including reagents, calibrators, buffers, controls, etc. and complete batch records while maintaining cGMPs and GDP standards.
• Perform in-process testing using clinical analyzers and analyze raw data for in-process adjustments and product release.
• Review other manufacturing operators/scientist’s batch records.
• Maintain and analyzes lot histories for trends and discrepancies.
• Perform laboratory activities including Weighing, transferring, and mixing required chemicals and performing product filtration.
• Participate in process improvement projects to improve operational efficiencies and support business needs.
• May modify SOPs, work instructions and reports with mentorship.
• Initiate and support investigations for quality documentation including NCARS, CAPAs, and Variances.
• Maintain and troubleshoot testing and formulations equipment as appropriate.
• Keep department supervisor and/or manager updated on all issues
• Perform other job duties as the need arises.