Overview Renew Labs is the largest provider of Nanopore based sequencing in the U.S. Founded in 2022, Renew has built an full-scale 20,000 square-foot

CAP/CLIA

commercial lab and is scaling operations. We are seeking a detail-oriented and experienced Quality Assurance Supervisor to oversee and maintain our quality systems in compliance with industry standards and regulatory requirements. The ideal candidate will play a key role in ensuring that our products and processes meet clinical lab regulations, and other relevant standards such as GMP. This position offers an opportunity to lead quality assurance initiatives within a dynamic environment committed to excellence and regulatory compliance. Duties Supervise and coordinate daily quality assurance activities to ensure adherence to established quality systems and regulations. Develop, implement, and maintain quality procedures, policies, and documentation aligned with industry standards such as

ISO 15189, ISO 13485, ISO 17025, ICH Q10, FDA

Part 11, Part 820, Part 210/211, CAP, CLIA, NYSDOH CLEP, and other biotech or clinical requirements. Support regular audits and inspections to verify compliance with regulatory standards and internal quality protocols. Lead investigations of quality issues or deviations, identify root causes, and implement corrective and preventive actions. Collaborate with cross-functional teams including manufacturing, regulatory affairs, and laboratory personnel to ensure continuous improvement of quality processes. Train staff on quality systems, regulatory requirements, lab practices, and proper documentation procedures. Prepare for inspections by regulatory agencies and facilitate successful audit outcomes. Monitor key quality metrics and prepare reports for management review and quality indicator review meetings. Requirements Proven experience in quality assurance within biotech or clinical environments with knowledge of GMP practices. Strong understanding of FDA regulations including Part 11, Part 820, Part 210/211, as well as other relevant standards such as

CAP, CLIA, NYSDOH CLEP.

Familiarity with international standards such as

ISO 15189, ISO 13485, ISO 17025, ICH Q10.

Demonstrated ability to develop and maintain robust quality systems in regulated environments. Excellent leadership skills with the ability to supervise teams effectively. Strong analytical skills for root cause analysis and problem-solving. Effective communication skills for training staff and collaborating across departments. Attention to detail with a commitment to maintaining high-quality standards in all activities. This role is integral to ensuring our products meet rigorous safety and quality standards while maintaining full compliance with applicable regulations. We seek a dedicated professional eager to uphold excellence within a regulated environment that values precision and continuous improvement.

Pay:

$80,000.00 - $110,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Flexible schedule Flexible spending account Health insurance Health savings account Life insurance Paid time off Vision insurance

Education:

Bachelor's (Required)

Experience:

Quality assurance: 2 years (Preferred)

Location:

Pleasant Grove, UT 84062 (Preferred)

Work Location:

In person