Senior Quality Specialist - Remote - Invitae
Invitae, now part of Labcorp, is seeking a motivated and self-driven Senior Quality Specialist to join its team! The Quality Assurance team provides vital support to Labcorp’s laboratories, senior management as well as our clients. This position will be responsible for supporting projects and activities related to quality assurance, quality improvement, quality training, and other responsibilities of the Quality Assurance department. The Senior Quality Specialist allows the laboratory to provide quality results to our providers and patients, which increases customer satisfaction and solidifies loyalty for our company. Please note: this position has the option to be 100% remote, or physically located at our laboratory in San Francisco, CA. The schedule for this position will be: Monday-Friday, 8am-5pm. Time zone local to candidate. Responsibilities:
- Administer the electronic Quality Management System (Jira) used for documenting quality management activities. This includes but is not limited to Change Management, Supplier Quality, Audit Program, Corrective Action Program, Incident Management, Document Control, etc.
- Work cross functionally with team members and leaders to maintain and improve system performance. Ensure improvement plans are communicated effectively and completed on time
- Train and mentor subject matter experts in required elements and best practices of assigned Quality Programs
- Act as Quality Program subject matter expert supporting external audits
- Monitor, trend, analyze and report Quality Program data at Site Management Review meetings. Ensure metrics are thorough and complete
- Provide recommendations for process and program improvements. When and as appropriate, work towards achieving improvement projects utilizing lean six sigma methods
- Support Quality Lead and team with additional Quality Programs, as necessary
Requirements:
- Bachelor’s degree in a relevant scientific discipline or engineering with strong technical capability
- Minimum of 7 years of experience in Quality Assurance and/or Regulatory Affairs
- Experience in clinical diagnostic laboratory, medical device or related industry
- Experience managing or leading quality management programs with a solid understanding of processes
Preferred Qualifications:
- Knowledge and/or experience with regulatory requirements including CLIA, NYSDOH and CAP
- Knowledge and/or experience with FDA regulations and ISO standards (e.g. QSR 820, ISO 13485 or ISO 15189)
- Yellow or Green Belt in Lean Six Sigma.
Application Window Date Thru: 11/19/2024 Pay Range: $95,000-$135,000 annual 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: As an EOE/AA employer, Labcorp strives for diversity and inclusion 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 of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), 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. 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. Apply Job!