Senior Qualiity Assurance Auditor

Senior Quality Assurance Assurance:
•Supervise and train the Quality Assurance Auditors for the biological Services Division.
•Serve as a primary Quality Assurance Unit responsible person for studies performed by the Biological Testing Services Division.
•Coordinate and perform inspections/audits of lab studies and facilities.
•As necessary, coordinate and perform inspections/audits of subcontractors and vendors.
•Assist Manager, Compliance with hosting of client/regulatory audits.
•Review/audit and approve final reports and study raw data.
•Prepare, track, review, issue and approve as required Protocols, STMs, SOPs and related documents. Serve as primary QAU reviewer for documentation related to the Biological Testing Services Division.
•Support the coordination if the company technical training program for the Biological Testing Services Division.
•Participate in the planning and presentation of the regularly scheduled compliance training programs for employees.
•As required, provide assistance for the company raw material/critical components receipt/approval program.•Oversee and review validation area processes and procedures, making recommendations for changes and/or improvements.
•Interact with laboratory supervisors/managers, customers, and suppliers/vendors as necessary.
•Perform all other related duties as assigned.
REQUIREMENTS
•Education: Bachelor’s degree (B.A./B.S.) or equivalent in a related discipline.
•Experience: 2 years related experience and or training.
•An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
•Certification/Licensure: N/A
•Other: