Laboratory Quality Manager
About The Position
The PASL Quality Manager owns and leads the Quality Management System (QMS) for Phigenics Analytical Services Laboratory’s two environmental testing laboratories, which perform water microbiology and chemistry testing in support of building water management programs. The laboratories are accredited under TNI/NELAP and are seeking ISO/IEC 17025:2017 accreditation. The manager ensures ongoing QMS improvement, maintenance, and alignment with applicable accreditation, regulatory, and customer requirements, and has authority to identify quality issues and initiate corrective action. This role leads the accreditation program and supervises and develops the quality team. The role is based at the PASL location in Fayetteville, Arkansas, with periodic travel between the Fayetteville and Warrenville, Illinois laboratories as needed. It includes occasional overtime, sometimes with little or no notice, and responsibility for laboratory safety, quality systems, audits, staff development, equipment calibration, and data integrity.
Requirements
- Bachelor’s degree in Chemistry, Microbiology, Biology, or a related scientific field.
- At least 5 years of laboratory quality experience, including direct, hands-on experience implementing and maintaining an ISO/IEC 17025 Quality Management System.
- Demonstrated experience leading internal and external audits, CAPA programs, and management review processes.
- Working knowledge of measurement uncertainty, method validation or verification, and proficiency testing programs.
- Prior people-management experience and the ability to train, coach, mentor, set clear expectations, and support staff development.
- Strong technical verbal and written communication skills, including policy and procedure development and audit reporting.
- Strong time management, attention to detail, and interpersonal skills.
- Ability to work overtime occasionally, sometimes with little or no notice.
- Knowledge of computers, MS Office, LIMS and other laboratory software, and shipping programs.
Nice To Haves
- Prior experience serving as a laboratory’s designated Quality Manager, or in an equivalent role under ISO/IEC 17025 accreditation.
- ISO/IEC 17025 Internal Auditor or Lead Assessor training or certification.
- ASQ Certified Quality Auditor (CQA) or a similar credential.
Responsibilities
- Own, implement, and continually improve the PASL Quality Management System in conformance with ISO/IEC 17025:2017, TNI Standard 2016, and other applicable standards.
- Serve as the primary contact with accrediting bodies for accreditation matters, including scheduling, hosting, and responding to assessments and surveillance audits.
- Plan and execute the annual internal audit program across both laboratory locations and lead or support external accreditation audits.
- Lead the Corrective Action and Preventive Action (CAPA) process, including root cause analysis, effectiveness verification, and timely closure of findings.
- Own the management review process and compile quality metrics, audit results, customer feedback, and QMS performance trends for leadership review.
- Oversee document control for the quality manual, SOPs, forms, and records across laboratory workflows, including annual review and version control.
- Direct equipment calibration and preventive maintenance programs and ensure metrological traceability for measurements within the accreditation scope.
- Oversee measurement uncertainty budgets and support method validation or verification for new or revised test methods before adding them to the accreditation scope.
- Design, administer, and evaluate proficiency testing and interlaboratory comparison programs; investigate and resolve unacceptable performance.
- Recruit, train, mentor, and manage the performance of quality specialists; ensure competency assessments and quality training records are current and documented.
- Review and maintain the PASL Safety Manual annually and support the Safety Program with the Phigenics safety team.
- Maintain working knowledge of PASL software and laboratory systems and ensure data integrity within them.
- Travel periodically between the Warrenville, Illinois and Fayetteville, Arkansas laboratories to maintain consistent quality practices.
- Develop, maintain, and improve PASL SOPs, quality documentation, workflow processes, and quality-related training.
- Oversee the laboratory safety program and related procedures.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
