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Sterigenicsposted 3 months ago
Mid Level
Salt Lake City, UT
Ambulatory Health Care Services
About the position
The Quality Audit Team Manager provides oversight of one or more of the quality audit teams and manages day-to-day operations, supervising team members. Additionally, the Quality Audit Team Manager is accountable for ensuring training needs of their team are addressed, and for the regulatory compliance and policy & procedural compliance of the team.
Responsibilities
- Establish and monitor lab section specialization for Audit Team members
- Oversee the continuous improvement processes efforts of the Audit Team
- Train, supervise, and mentor the Audit Team
- Lead Audit Team meetings
- Review and trend general adverse quality events (unexpected results, retests, deviations, amended reports)
- Review SOPs in MasterControl
- Review protocols, raw data, validations, or final reports as needed
- Perform GLP audits as needed
- Perform Internal Audits as needed/requested by the Internal Audit Coordinator
- Perform other duties as assigned.
Requirements
- Demonstrated experience in a Supervisory capacity leading QA teams
- 2+ years of leadership experience with a Bachelor's Degree in a relevant Life Science
- 4+ years of directly related experience with an Associate's Degree or HS Diploma
- At least one of the following: Supervisory Training or experience, Business Training or experience, MIT M.B.A.
- At least one of the following Quality Requirements: NRM or NLM Quality Certification, CQE, CBA, or CQA, Sterilization Specialist Certification, Other job specific certifications (as approved by the career board)
