QA Auditor San Francisco CA

Excellent opportunity in the Quality Assurance Department at Invitae and Labcorp. in the Quality Departmentin San Francisco, CA.

Do you have 12 years' experience in Quality Assurance?  Do you have extensive knowledge regarding the regulatory body and processes to develop resolutions and corrective or preventative actions? Are you detail-oriented and have strong skills to work with Root Cause Analysis, Sop’s, Policies and Procedures?   Do you love collaborating with other groups to solve problems and increase the efficiency of internal processes?  If you have any of these, then this may be the position for you!!

• Provide internal audit services in compliance with the Corporate Audit Program and Invitae Quality System.

• Coordinate, maintain and publish the Audit schedule.

• Conduct internal audits for Clinical Operations.

• Ensure that the Internal Audit program is effective in assessing the health of the Clinical Laboratory Quality Management System.

• Collaborate with Quality, Regulatory and Laboratory leaders to ensure ongoing audit readiness of the site.

• Work with team leads to ensure findings are addressed in a timely fashion and meet regulatory compliance.

• Provide Audit KPIs as part of Quality Management Review.

• Work cross-functionally to lead and provide the necessary support for external audits.  This includes regulatory, client and vendor audits.

• Support quality improvement initiatives and other Quality System activities, as assigned.

• Bachelor’s degree in scientific discipline (required).

• 12+ years’ work experience in the biologics industry, preferably in a laboratory setting.

• Experience working in a regulated clinical laboratory (CLIA /CAP/ FDA / ISO).

• Audit Certification (preferred)

• Experience hosting inspections from a regulatory agency (required).

• Experience conducting audits (internal or external 3rd party).

• Strong communication skills and ability to effectively communicate with people of all levels.

• Ability to interpret policies, procedures, and regulatory requirements.

• Ability to make decisions impacting product and sample safety based on independent judgment and discretion.

Location:  Onsite at 1400 16th Street, San Francisco, CA/Hybrid following training

Pay Range: $120,000 to $160,000/annually

applicable degrees/certifications, as

Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan.  Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here .

Labcorp is proud to be an Equal Opportunity Employer:

dditionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.

We encourage all to apply

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