Quality Assurance Supervisor

WISEcode•Kannapolis, NC

24d•Onsite

About The Position

The Quality Assurance Supervisor leads WISEcode Labs’ laboratory quality management system and is accountable for maintaining ISO/IEC 17025 accreditation and expanding its scope as required by key customers. The role ensures that methods, equipment, personnel, records, and reported results meet applicable standards, accreditation body requirements, and customer requirements. It safeguards laboratory impartiality and has authority to stop work or reports that do not meet quality requirements, coordinate resolution with technical and operational leaders, verify corrective actions, and authorize work resumption or report release under approved procedures. The role supports reliable turnaround times and the launch of new testing services, issues nutrition labels, and oversees the laboratory’s environmental health and safety program. WISEcode Labs is an independent third-party testing laboratory serving food, beverage, dietary supplement, ingredient, and adjacent consumer-health companies. Its work combines analytical instrumentation, method development, microbiology and chemistry expertise, and customer service for complex, recurring testing needs. The Quality Assurance Supervisor has direct access to the CEO to escalate quality, impartiality, data integrity, and accreditation risks. The role is onsite at the laboratory in Kannapolis, North Carolina; regular laboratory presence is essential, and occasional extended hours may be needed around assessments and customer audits.

Requirements

Bachelor’s degree in chemistry, microbiology, food science, or a related scientific discipline; equivalent experience may be considered.
At least five years of laboratory quality experience, including managing and coordinating a quality management system, audits, and accreditation activities.
Hands-on experience in an ISO/IEC 17025-accredited testing laboratory, including accreditation body assessments, document control, internal audits, CAPA, proficiency testing, competency records, and management review.
Working knowledge of method validation and verification, measurement uncertainty, metrological traceability, laboratory quality control, and data integrity principles across chemistry and microbiology.
Strong organization, written communication, investigation, and cross-functional leadership skills.
Sound judgment and the ability to uphold quality requirements under commercial pressure.
Regular onsite presence at the Kannapolis laboratory.

Nice To Haves

ISO/IEC 17025 internal auditor or lead assessor training.
ASQ certification (CQA, CMQ/OE) or equivalent.
Experience with LIMS, preferably QBench, and digital quality workflows.
Experience with scope expansion for techniques such as ICP-MS or LC-MS/MS.
Experience issuing nutrition labels, preferably using Panelgea, and COA reporting.
Experience managing an EH&S program.

Responsibilities

Own and maintain the quality management system, quality manual, annual quality calendar, and tracker for corrective and preventive actions, audit findings, and other quality actions.
Serve as the primary contact with the accreditation body; prepare for surveillance and reassessment visits, coordinate scope extensions, respond to findings, and track actions through timely closure.
Control use of accreditation symbols and accreditation claims across reports, quotations, the website, and marketing materials.
Maintain document control for quality and technical documents and records, including retention, protection, and retrieval.
Maintain the multi-year internal audit schedule, complete an annual audit risk assessment, conduct scheduled internal audits, and arrange independent audits of the QA function.
Maintain risk and customer complaint registers, prepare quarterly management reviews, record decisions, and follow actions to completion.
Lead handling of deviations, out-of-specification results, nonconforming work, complaints, and CAPA, including containment, impact assessments, customer notification or report recall where required, root-cause investigation, and effectiveness checks.
Manage the complaints process impartially, including acknowledgment, investigation, response, and trend analysis; technical leaders remain responsible for scientific conclusions.
Work with the Lab Manager to maintain competence requirements, training, supervision, and written authorizations for methods, data review, and report release.
Oversee calibration, verification, maintenance, metrological traceability, and control of reference standards, certified reference materials, and reagents; laboratory owners perform the work and provide evidence.
Verify that facilities and environmental conditions are monitored and recorded where they affect results.
Approve and monitor suppliers and subcontracted laboratories against documented criteria, including accreditation status and scope, and ensure customers are informed of subcontracted work.
Maintain proficiency testing and interlaboratory comparison plans, order samples for existing and expanded scope, review results, and investigate unsatisfactory performance.
Maintain internal quality-control requirements and review trends to detect drift before it affects reported results.
Set quality requirements for method development, validation, or verification; approve quality packages and control release of methods to routine customer testing.
Ensure method requirements and intended use are defined before development; review validation evidence and maintain readiness checklists and formal release records; route material changes through change control.
Ensure technical records support traceability and repeatability and that data integrity controls, including access, audit trails, and review of changes, are effective in instruments and the LIMS.
Own report-release procedures and the signatory authorization matrix; ensure reports contain required information, amended reports are identified, and trained backup signatories are available.
Maintain risk-based data review procedures and reviewer qualifications; perform selected review or qualified backup within documented authorization.
Prepare, review, and issue nutrition facts labels using Panelgea, ensuring values are traceable to approved test results.
Develop proficiency in the certificate of analysis reporting workflow and support COA review and release as needed.
Train and qualify backup personnel for nutrition label issuance.
Oversee EH&S policies, procedures, and training, keeping them current with applicable regulatory requirements.
Serve as the contact for building and facility-related matters; coordinate safety inspections, incident documentation, corrective actions, and safety training with Operations and designated EH&S support.
Maintain sanitation schedules and verification records; audit adherence to cleaning requirements and escalate gaps.
Escalate quality, impartiality, data integrity, and accreditation risks to the CEO and draw attention to affected work or reports when requirements are not met.