Senior Quality Assurance Manager.

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.

Responsibilities:

• 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.

Requirements:

• 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.

If this opportunity is attractive to you, please apply above or get in touch at:

joe.bell@lifesci-cm.com