Quality Assurance Supervisor

WISEcode•Kannapolis, NC

9d•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. The supervisor 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 resumption of work or report release under approved procedures. The role builds a quality system that supports reliable turnaround times and new testing services. It also issues nutrition labels and oversees the laboratory’s environmental health and safety program. The supervisor has direct access to the CEO to escalate quality, impartiality, data-integrity, and accreditation risks, and can escalate attention to affected work or reports when requirements are not met. WISEcode Labs is an independent third-party testing laboratory serving food, beverage, dietary supplement, ingredient, and adjacent consumer-health companies. It combines analytical instrumentation, method development, microbiology and chemistry expertise, and a high-touch service model. This position is onsite at the laboratory in Kannapolis, in the Charlotte metro area of North Carolina. Regular laboratory presence is essential; 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 ability to hold a quality position under commercial pressure.
Regular onsite presence at the laboratory in Kannapolis is essential.

Nice To Haves

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

Responsibilities

Own the quality management system and quality manual, and maintain the annual quality calendar for recurring QMS activities.
Track CAPAs, audit findings, and other quality actions, including owners, due dates, and evidence of completion.
Serve as the primary contact with the accreditation body; prepare for surveillance and reassessment visits, coordinate scope extensions, respond to findings, and track them through timely closure.
Control use of the accreditation symbol 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 at least one internal audit risk assessment annually, conduct scheduled audits, and arrange independent auditing of the QA function.
Maintain risk and customer complaint registers, drive improvement actions, prepare quarterly management reviews, record decisions, and follow actions to completion.
Lead the processes for deviations, out-of-specification results, nonconforming work, and CAPA, including containment, impact assessment, customer notification or report recall where required, root-cause investigation, and effectiveness checks.
Own the complaints process by acknowledging, impartially investigating, responding to complainants, and trending complaints for systemic causes.
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; verify monitoring of facilities and environmental conditions 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 a proficiency testing and interlaboratory comparison plan covering the accredited scope; order samples, 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, and verification; approve quality-package completeness and control method release to routine customer testing.
Ensure intended use, matrices, analytes, method source, customer requirements, reporting limits, and accreditation status are defined before method development starts, and that validation or verification plans have predefined acceptance criteria.
Review method evidence as relevant, maintain readiness checklists and formal release records, and route material changes through change control.
Ensure technical records support traceability and repeatability, and that data-integrity controls in instruments and the LIMS are effective.
Own report-release procedures and the signatory authorization matrix; ensure reports contain required information, amended reports are identified, and qualified 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 label values trace 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 label issuance.
Oversee EH&S policies, procedures, and training; serve as point of contact for building and facility matters; coordinate safety inspections, incident documentation, corrective actions, and safety training.
Maintain the sanitation schedule and verification records; audit adherence to cleaning requirements and escalate gaps.