Quality Assurance Supervisor

Position Summary

The Quality Assurance supervisor leads the 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 the standard, accreditation body requirements, and customer requirements. The QA Supervisor safeguards the impartiality of the laboratory, holds the authority to stop work or reports that do not meet quality requirements. The role coordinates resolution with technical and operational leaders, verifies corrective actions, and authorizes resumption of work or report release in accordance with approved procedures. The QA supervisor builds a quality system that supports reliable turnaround times and the launch of new testing services. The role also issues nutrition labels and oversees the laboratory’s environmental health and safety (EH&S) program.

Key Responsibilities

Management system and accreditation - ISO/IEC 17025:2017.
• Own the quality management system and quality manual. Maintain the annual quality calendar, a schedule of recurring QMS activities such as internal audits, management reviews, proficiency testing, calibrations, and accreditation body visits. Maintain a tracker for CAPAs, audit findings, and other quality actions that records the owner, due date, and evidence of completion for each item.
• Serve as the primary contact with the accreditation body. Prepare for surveillance and reassessment visits, coordinate scope extensions, respond to findings with root cause and evidence, and track them through closure on time.
• Control the use of the accreditation symbol and claims of accreditation on reports, quotations, the website, and marketing materials, so that accredited and non-accredited results are clearly distinguished.
• Maintain document control for the quality manual, SOPs, forms, and controlled external documents (such as published standards and reference methods), and control of quality and technical records, including retention, protection, and retrieval.
• Maintain the multi-year internal audit schedule, completing at least one internal audit risk assessment annually to keep it current and compliant. Conduct internal audits as scheduled and arrange independent auditing of the QA function itself.
• Maintain the risk and customer complaint registers and drive improvement actions. Prepare the quarterly management review, record decisions, and follow actions to completion.
Nonconforming work, complaints, and corrective action
• Lead the process for deviations, out-of-specification results, nonconforming work, and CAPA. Ensure documented containment, impact assessment on previously issued results, customer notification and recall of reports where required, root-cause investigation, and effectiveness checks before closure.
• Own the complaints process: acknowledge, investigate impartially, respond to the complainant, and trend complaints for systemic causes. Technical leaders remain responsible for scientific conclusions.
Personnel, equipment, and external providers
• With Lab manager, maintain competence requirements, training, supervision, and written authorizations for each method, data review, and report release. No one performs or authorizes work outside documented competence.
• Oversee the calibration, verification, and maintenance program, metrological traceability of measurement results, 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 their accreditation status and scope, and ensure customers are informed of subcontracted work.
Assuring the validity of results
• Maintain a proficiency testing and interlaboratory comparison plan that covers the accredited scope at the frequency required by the accreditation body. Order proficiency testing samples for the existing scope and for methods added through scope expansion, review results, and investigate unsatisfactory performance.
• Maintain internal quality control requirements (blanks, spikes, duplicates, check standards, control charts) and review trends to detect drift before it affects reported results.
Methods and validation

R&D and technical team develop, validate, or verify methods. QA sets the requirements, approves the completeness of the quality package, and controls release to routine customer testing.
• Require that intended use, matrices, analytes, method source, customer requirements, reporting limits, and accreditation status are defined before development starts.
• Require an approved validation or verification plan with predefined acceptance criteria. Review evidence for selectivity, accuracy or recovery, precision, calibration, LOD and LOQ, matrix effects, carryover, and robustness as relevant, for standard, modified, and laboratory-developed methods.
• Maintain a method readiness checklist and formal release record covering SOPs, QC criteria, equipment, competency, capacity, permitted accreditation claims, and post-launch monitoring. Route material changes through change control.
Data integrity
• Ensure technical records allow each result to be traced and repeated, and that data integrity controls (access, audit trails, review of changes) are effective in instruments and in the LIMS.
• Own the report release procedure and signatory authorization matrix. Ensure reports contain the required information, that amended reports are clearly identified, and that trained backup signatories prevent dependence on one person.
• Maintain risk-based data review procedures and reviewer qualifications. Perform selected review or qualified backup within documented authorization; routine review remains with designated technical reviewers.
Nutrition labeling and reporting
• Prepare, review, and issue nutrition facts labels using Panelgea, ensuring label values are traceable to approved test results.
• Develop working proficiency in the certificate of analysis (COA) reporting workflow, which closely parallels label issuance, and support COA review and release as needed.
• Train and qualify backup personnel for label issuance so the workflow does not depend on one or two people.
Environmental health and safety (EH&S) and sanitation
• Oversee and maintain EH&S policies, procedures, and training, keeping them current with applicable regulatory requirements.
• Serve as the point of contact for the building and facility-related matters.
• Coordinate safety inspections, incident documentation, corrective actions, and safety training with Operations and designated EH&S support.
• Maintain the sanitation schedule and verification records. Supervisors assign and oversee cleaning; QA audits adherence and escalates gaps.

Quality, authority, and independence

The QA 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. 

Candidate Qualifications & Experience

Required

• 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 QMS, 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 QC, and data integrity principles across chemistry and microbiology.
• Strong organization, written communication, investigation, and cross-functional leadership skills, with the judgment to hold a quality position under commercial pressure.

Preferred

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

Location

This role is onsite at WISEcode Labs in Kannapolis, in the Charlotte metro area of North Carolina. Regular presence in the laboratory is essential; Occasional extended hours may be needed around assessments and customer audits.

Equal Opportunity

WISEcode Labs is committed to building a high-performing, inclusive workplace. Employment decisions are based on business needs, role requirements, and individual qualifications, without regard to protected characteristics under applicable law.

This position specification describes the primary scope of the role and is not intended to be an exhaustive list of every duty or measure.