QA Auditor - Laboratory Corporation : Job Details

Excellent opportunity in the Quality Assurance Department at Invitae and Labcorp.We have a position for a Quality Assurance Auditor in the Quality Department in San Francisco, CA.

Together, Invitae and Labcorp make it easier to access genetic data, uncover personal health insights, and deliver the right care for each patient's needs. Are you looking to join an organization? This is a great opportunity to grow a career at Invitae and Labcorp.

Do you have 12 years' experience in Quality Assurance? Do you have extensive knowledge regarding regulatory bodies and processes to develop resolutions and corrective or preventative actions? Are you detail-oriented and have strong skills to work with Root Cause Analysis, SOPs, 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!

Responsibilities include:

• Providing internal audit services in compliance with the Corporate Audit Program and Invitae Quality System.
• Coordinating, maintaining, and publishing the Audit schedule.
• Conducting internal audits for Clinical Operations.
• Ensuring the effectiveness of the Internal Audit program in assessing the health of the Clinical Laboratory Quality Management System.
• Collaborating with Quality, Regulatory, and Laboratory leaders to ensure ongoing audit readiness.
• Working with team leads to ensure findings are addressed promptly and meet regulatory standards.
• Providing Audit KPIs for Quality Management Review.
• Leading and supporting external audits, including regulatory, client, and vendor audits.
• Supporting quality improvement initiatives and other activities as assigned.

Minimum qualifications:

• Bachelor's degree in a scientific discipline.
• 12+ years' 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 regulatory agencies.
• Experience conducting internal or external audits.
• Strong communication skills and ability to communicate effectively at all levels.
• Ability to interpret policies, procedures, and regulatory requirements.
• Ability to make decisions impacting product and sample safety based on independent judgment.

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

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

All offers will be based on skills, experience, degrees/certifications, and market data.

Benefits: Employees working 20+ hours/week are eligible for comprehensive benefits including Medical, Dental, Vision, Life, STD/LTD, 401(k), PTO/FTO, Tuition Reimbursement, and Employee Stock Purchase Plan. Part-time employees working less than 20 hours are eligible for 401(k) only. For more details, click here.

Equal Opportunity Employer:

Labcorp values inclusion and does not tolerate discrimination. Employment is based on qualifications and merit, regardless of protected characteristics. Applicants with arrest or conviction records will be considered as per law.

We encourage all to apply.

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