Job Title:

Quality Manager -- Job Summary 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 Manager to oversee and maintain the integrity of our quality systems. The ideal candidate will play a pivotal role in ensuring compliance with industry standards, enhancing quality processes, and supporting continuous improvement initiatives. This position requires a strong background in clinical laboratory quality assurance/regulatory affairs or pharmaceutical/medical device manufacturing quality, with a focus on implementing and managing robust quality systems on a day-to-day basis. -- Duties Maintain and improve comprehensive quality systems and regulatory requirements such as NC/CAPA, training/competency, audits, assay validations, IQ/OQ, material qualification, document control, software validation. Monitor daily operations to ensure adherence to quality policies, procedures, and regulatory guidelines. Conduct regular audits of processes, products, and documentation to identify areas for improvement. Lead investigations into quality issues, non-conformances, and deviations, implementing corrective and preventive actions. Collaborate with cross-functional teams to ensure quality objectives are met. Provide training and guidance to staff on quality standards, procedures, and best practices. Prepare detailed reports on quality metrics, audit findings, and compliance status for management review. Stay current with evolving industry regulations and standards related to clinical labs or pharmaceutical/medical device manufacturing. Support validation activities and review validation protocols and reports as needed. Manage documentation related to quality systems to ensure accuracy, completeness, and compliance. -- Experience Proven experience in managing quality systems within clinical laboratory QA/RA or pharmaceutical/medical device manufacturing environments. Strong understanding of industry standards such as

CAP, CLIA, CLEP, ISO

13485, GxP (Medical Device or Pharma only), or relevant regulatory frameworks. Prior experience conducting audits, investigations, and implementing corrective actions. Familiarity with regulatory compliance requirements specific to clinical labs or medical device/pharmaceutical manufacturing is preferred. Excellent communication skills with the ability to train teams and present findings effectively. Demonstrated leadership in maintaining high-quality standards within complex operational settings. -- This role offers an engaging opportunity for a dedicated professional passionate about maintaining excellence in quality management. If you possess the required expertise in clinical lab QA/RA or pharmaceutical/medical device manufacturing environments and thrive in a dynamic setting focused on continuous improvement, we encourage you to apply.

Pay:

$80,000.00 - $120,000.00 per year

Benefits:

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

Education:

Bachelor's (Required)

Experience:

Clinical laboratory: 1 year (Preferred) Quality systems: 2 years (Required)

GMP:

1 year (Preferred) Ability to

Commute:

Pleasant Grove, UT 84062 (Required)

Work Location:

In person