Senior Quality Assurance Manager.
Hayward, San Francisco Bay Area - United States
Competitive, depending on experience
As a Senior Quality Assurance (QA) Manager, you will ensure compliance with CLIA/CAP and assist with IVD through audits and vendor assessments, in a rapidly-growing liquid biopsy & oncology laboratory in Hayward, San Francisco Bay Area.
- Lead QA functions for CLIA/CAP lab and assist with IVD QA as required.
- Participate in the resolution of pre-examination, examination, and post-examination specimen CLIA lab issues and CAPA review and resolution.
- Assist with deviations, CAPA and Quality Events.
- Ensure compliance with the CLIA Lab Quality Assurance Program.
- Serve as Quality representative for CLIA/CAP related Quality Events/CAPAs (Corrective & Preventive Action) and clinical research projects.
- Lead quality audits (examination of an organization's quality management system, QMS) of laboratory operations, document audit findings, and report results to senior leadership.
- Perform required duties in compliance with CLIA, OSHA, CAP, New York State, California State, FDA and other laboratory regulatory authorities.
- Participate in cross-functional laboratory quality projects.
- Conduct internal audits, critical phase inspections and vendor audit/assessments.
- Promote a mindset of quality and continual process improvement.
- Write, review, and revise CLIA related policies, protocols, and procedures.
- Maintain familiarity with CLIA and CAP regulations.
- Perform related duties as assigned by supervisor
- Maintain compliance with all company policies and procedures
- Support safety processes in lab.
- Minimum of 5 years of experience in CLIA Quality Assurance Role
- Prior lab experience in a molecular diagnostic setting highly preferable
- BS in biology or related field or equivalent experience
- Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers
- Excellent computer proficiency (MS Office – Word, Excel and Outlook.
- Must be able to work under pressure and meet deadlines, while maintaining a positive attitude and providing exemplary customer service.
- Ability to work independently and to carry out assignments to completion within parameters of instructions given, prescribed routines, and standard accepted practices.
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