Manage team responsible for the formulation of reagents, production into filled vials, and their accurate testing and documentation on tight deadlines. Collaborated closely with multiple departments for product transfers from R&D to Operations and ongoing process validations.•Developed and implemented procedures to reduce material costs, production time, and prevent errors.•Worked in teams across departments to establish production methods, documentation, and specifications for new products.•Coordinated with other groups to pool resources in order to meet production requirements.•Managed and evaluated test results to identify trends and avoid production of non-conforming product, minimizing waste and preventing material scrap.•Wrote and presented final reports, trend data, and troubleshooting analysis.•Ensured the continued quality of product with a reduced workforce while maintaining a motivational atmosphere that helped the department meet difficult goals.•Prepared for and participated in internal and ISO auditing. Resolved all observations from audits.•Wrote and delivered performance reviews. Provided continuous feedback throughout the year.•Negotiated with outside vendors for equipment maintenance and repair.

Tested kit lots according to established procedure. Maintained lab and equipment. Kept accurate records of results. Assisted in troubleshooting both in the lab and through data analysis. Developed and maintained databases for tracking and trending of testing data. Selected as Acting Supervisor when Supervisor was absent