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 experience in Quality Assurance? Do you have good 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!!
Want more jobs like this?
Get jobs in San Francisco, CA delivered to your inbox every week.
Duties and Responsibilities:
- 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.
Minimum Qualifications:
- 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 trainig
Pay Range: $120,000 to $160,000/annually
All job offers will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data.
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:
Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
We encourage all to apply
If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement.