Lynne Sheets Email & Phone Number

Madison, Wisconsin, United States

Madison, Wisconsin Area

• Played a key role in the design and implementation a quality management system that is compliant to ISO 13485.• Established a Material Review Board and reduced average time for complaint closure from 30 days to 5 days.• Administer the NCMR system and facilitate MRB meetings.• Review production and QC records and perform product release of products. • Lead CAPA investigators by providing guidance to drive to root cause analysis and practical corrective and preventive solutions. • Perform supplier qualifications, material issue resolution, drive supplier corrective actions, and manage approved supplier list.• Lead internal Quality System audits.• Administer incoming and in-process inspection program utilizing statistical techniques as appropriate.• Guide design and development projects through the requirements of ISO 13485. • Mentor and oversee performance of new hires in QA.• Train all new employees in the Quality System and manage training records.• Mentor Production Scientists in complaint and nonconformance investigations.• Assist metrology with IOQ review and equipment management.

Product development.• Responsible for development of new molecular cloning products.• Assisted Senior Scientists in design of new products. • Developed and implemented scale up of new products for manufacturing.• Improved performance of existing products• Wrote Standard Operating Procedures (SOP) for new products• Trained and mentored manufacturing personnel.

Manufacture and development of competent cells.• Trained and supervised new hires.• Developed new products.• Wrote Standard Operating Procedures (SOP).• Performing Quality control testing of competent cells.• Developed quality control tests and documentation.• Managed inventory and production planning.

Ms Biotechnology

Bs Biology

As Biotechnology