Quality Control Manager

LIGHT LABS

Powering a healthier food system through data, transparency, and accountability.

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Light Labs | Ann Arbor, MI (On-site, Lab) | Supporting Ann Arbor and Salt Lake City | Reports to the Quality Director

Are you the quality professional people turn to when a result has to hold up? Someone who wants to be the one who decides when a number is ready to leave the lab? Then you'll be a great fit as our Quality Control Manager. You'll own the day-to-day quality system across both of our labs, decide when data is fit to release, drive corrective actions to closure, and be the person who notices a drifting instrument before a client does.

You’ll also serve as deputy to the Quality Director and cover for them when they’re out, which means being ready to speak for quality in front of an assessor, a client, or the lab floor.

Light Labs returns results in about three days where the industry takes seven to fourteen, at sub-ppb detection, under ISO/IEC 17025. Brands put those numbers on their product pages and inside their compliance filings for Prop 65, CA AB 899, and Amazon.

None of that matters if the results aren’t defensible. That’s where you come in.

• The quality system and accreditation. Maintain our ISO/IEC 17025 QMS: the quality manual, SOP lifecycle, document and record control, and revision history. Own change control for methods, instruments, software, and procedures, including the impact assessment.

• Audit readiness, year-round. Run the internal audit program from scheduling through closure. When the accreditation body comes in, prepare for the assessment, host it, and close the findings with evidence.

• One standard across two sites. Keep the quality system consistent so a result means the same thing in Ann Arbor and Salt Lake City.

• The call on release. Do the initial review of out-of-specification and out-of-trend results, decide whether a result is fit to release, and elevate when it isn't.

• Investigations that close. Lead nonconformance, deviation, and CAPA investigations from initiation through root cause to effectiveness check. Investigate client complaints and quality inquiries, and write the responses.

• Data integrity. Hold LIMS records and instrument raw data to attributable, legible, contemporaneous, original, and accurate.

• The control chart program. Set limits, review charts on a defined cadence, and act on shifts and trends.

• Method and instrument performance. 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.

• The numbers leadership sees. Report OOS rates, CAPA aging, PT performance, and on-time closure into management review, and flag the trends that point to process or equipment problems.

• Outside labs and suppliers. Qualify and monitor subcontracted and reference labs, review their results before they reach a client report, and evaluate the critical suppliers and consumables that affect result quality.

• Training and competency. Own analyst authorization, requalification, and the documented evidence that our analysts stay competent.

• Quality built in, not bolted on. Work with our software team to build quality checks directly into our LIMS and automation, and with technicians and chemists to keep standards consistent across every workflow.

• Staying current. Track changes to ISO/IEC 17025, FDA, and USP requirements and translate them into practice.

• Owned a quality subsystem end to…