Quality Control Manager

Light Labs•Ann Arbor, MI

42d•Onsite

About The Position

The Quality Control Manager will own the day-to-day quality system across both of Light Labs' locations, deciding when data is fit to release, driving corrective actions to closure, and proactively identifying instrument issues. This role also serves as deputy to the Quality Director, covering for them when necessary and representing quality in discussions with assessors, clients, and the lab floor. The position requires a strong understanding of quality systems in an accredited testing environment and the ability to communicate effectively to drive improvements.

Requirements

Owned a quality subsystem end to end (CAPA, internal audit, document control, training, or method validation) in an accredited testing lab or regulated manufacturing environment.
Supported an ISO/IEC 17025 accreditation assessment directly, with a working knowledge of the standard.
Run OOS and deviation investigations, including root cause analysis and CAPA closure.
Applied control chart methodology and QC trending in practice.
Written investigations, SOPs, and audit responses that held up under review.
Worked in LIMS and QMS software and speak the terminology.
A degree in chemistry, biology, engineering, or a related field.
Real communication skills and the confidence to lead.
Willingness to be on-site in Ann Arbor, MI, with regular time on the lab floor, PPE in lab areas, and occasional travel to Salt Lake City.

Nice To Haves

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

Responsibilities

Maintain the ISO/IEC 17025 QMS, 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.
Prepare for, host, and close findings from accreditation body assessments.
Ensure consistency of the quality system across the Ann Arbor and Salt Lake City labs.
Perform initial reviews of out-of-specification and out-of-trend results, and decide on result release.
Lead nonconformance, deviation, and CAPA investigations, including root cause analysis and effectiveness checks.
Investigate client complaints and quality inquiries, and write responses.
Ensure data integrity for LIMS records and instrument raw data (attributable, legible, contemporaneous, original, and accurate).
Manage the control chart program, including setting limits, reviewing charts, and acting on 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, PT performance, and on-time closure into management review.
Qualify and monitor subcontracted and reference labs, and evaluate critical suppliers and consumables.
Own analyst authorization, requalification, and documented evidence of analyst competency.
Collaborate with the software team to build quality checks into LIMS and automation.
Work with technicians and chemists to ensure consistent standards across workflows.
Track changes to ISO/IEC 17025, FDA, and USP requirements and implement them.