Quality Control Lead

Light Labs•Ann Arbor, MI

19h•Onsite

About The Position

Light Labs is hiring a Quality Control Lead to own the day-to-day quality system across its Ann Arbor and Salt Lake City labs. Based on-site in Ann Arbor, the role maintains the ISO/IEC 17025 quality management system, ensures consistent quality practices across sites, and determines whether results are fit for release. The lead serves as deputy to the Quality Director and covers for them when needed, including representing quality to assessors, clients, and lab staff. The role includes maintaining quality documentation and records; managing change control; leading internal audits and accreditation assessment readiness; investigating out-of-specification and out-of-trend results, deviations, nonconformances, CAPAs, and client complaints; and ensuring data integrity in LIMS and instrument records. It also oversees control charts, proficiency testing, method validation and verification support, equipment qualification and calibration records, stability studies, environmental monitoring, external laboratories and suppliers, and analyst training and authorization. The Quality Control Lead reports quality metrics and trends into management review, collaborates with software teams to embed quality controls in LIMS and automation, and works with laboratory staff to maintain consistent standards across workflows. The role requires regular time on the lab floor, PPE in lab areas, and occasional travel to Salt Lake City.

Requirements

Experience owning a quality subsystem end to end—such as CAPA, internal audit, document control, training, or method validation—in an accredited testing lab or regulated manufacturing environment.
Directly supported an ISO/IEC 17025 accreditation assessment and have a working knowledge of the standard.
Experience running OOS and deviation investigations, including root cause analysis and CAPA closure.
Practical experience applying control chart methodology and QC trending.
Ability to write investigations, SOPs, and audit responses that withstand review.
Experience working in LIMS and QMS software and familiarity with their terminology.
Degree in chemistry, biology, engineering, or a related field.
Strong communication skills and confidence leading others through changes and representing the Quality Director when needed.
Willingness to work on-site in Ann Arbor, Michigan, spend regular time on the lab floor, wear PPE in lab areas, and travel occasionally to Salt Lake City.

Nice To Haves

Dietary supplement, food, or consumer goods testing experience, including heavy metals, pesticides, microbiology, or nutritional analysis.
Knowledge of FDA cGMP (21 CFR 111 or 117), USP methods, and state or retailer requirements such as Prop 65, CA AB 899, or Amazon requirements.
Experience supervising or mentoring quality or laboratory staff.
Quality experience across more than one site or laboratory.
ASQ CQA, CQE, or CMQ/OE certification, or formal internal auditor training.
Experience validating software or automated data flows in a regulated environment.

Responsibilities

Maintain the ISO/IEC 17025 quality management system, including the quality manual, SOP lifecycle, document and record control, and revision history.
Own change control for methods, instruments, software, and procedures, including impact assessments.
Run the internal audit program from scheduling through closure and prepare for, host, and close accreditation assessments.
Maintain consistent quality practices across the Ann Arbor and Salt Lake City labs.
Initially review out-of-specification and out-of-trend results, determine whether results are fit for release, and escalate when they are not.
Lead nonconformance, deviation, and CAPA investigations from initiation through root cause analysis and effectiveness checks.
Investigate client complaints and quality inquiries and prepare responses.
Maintain data integrity for LIMS records and instrument raw data.
Set control chart limits, review charts on a defined cadence, and respond to shifts and trends.
Manage proficiency testing and interlaboratory comparisons and investigate unsatisfactory scores.
Support method validation and verification, including precision, accuracy, detection limits, and measurement uncertainty.
Maintain equipment qualification and calibration records, track stability studies, and run the Environmental Monitoring Program.
Report OOS rates, CAPA aging, proficiency testing performance, and on-time closure into management review, and flag relevant trends.
Qualify and monitor subcontracted and reference laboratories, review their results before they reach client reports, and evaluate critical suppliers and consumables.
Own analyst authorization, requalification, and documented competency evidence.
Work with the software team to build quality checks into LIMS and automation, and collaborate with technicians and chemists to maintain consistent standards.
Track changes to ISO/IEC 17025, FDA, and USP requirements and translate them into practice.
Serve as deputy to the Quality Director and cover for them when needed.