Laboratory Quality Manager
About The Position
Phigenics Analytical Services Laboratory (PASL) operates two environmental testing laboratories that perform water microbiology and chemistry testing in support of building water management programs. Both sites are accredited under TNI/NELAP and are seeking ISO/IEC 17025:2017 accreditation. The PASL Quality Manager owns and leads the Quality Management System (QMS) for both laboratories, ensuring its ongoing improvement, maintenance, and alignment with ISO/IEC 17025 and applicable accreditation, regulatory, and customer requirements. The role has authority to identify quality issues, initiate corrective action, and safeguard the integrity of laboratory operations. It leads the accreditation program and supervises and develops the quality team. The role is based at the Phigenics Analytical Services Laboratory in Warrenville, Illinois, and includes periodic travel between the Warrenville and Fayetteville, Arkansas laboratories. The Quality Manager works with laboratory and company leadership, the accrediting body, laboratory staff, and the Phigenics safety team. Safety is the company’s first priority.
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 a Quality Management System under ISO/IEC 17025.
- 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, including the ability to train, coach, mentor, set expectations, and support employee 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 as a team player.
- Ability to work overtime occasionally, sometimes with little or no notice.
- Computer proficiency, including 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 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 point of contact with accrediting bodies for accreditation matters, including scheduling, hosting, and responding to on-site assessments and surveillance audits.
- Plan and execute annual internal audits across both PASL locations and lead and 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, compiling quality metrics, audit results, customer feedback, and QMS performance trends for review with laboratory and company leadership.
- Oversee document control for the quality manual, SOPs, forms, and records across chemistry, microbiology, logistics, and manufacturing workflows, including annual review and version control.
- Direct the laboratory equipment calibration and preventive maintenance program 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 they are introduced into the accreditation scope.
- Design, administer, and evaluate the proficiency testing and interlaboratory comparison program; investigate and resolve unacceptable performance.
- Recruit, train, mentor, and manage the performance of PASL quality specialists; maintain current, documented staff competency assessments and quality training records.
- Review the PASL Safety Manual annually and support the PASL Safety Program with the Phigenics safety team.
- Maintain working knowledge of PASL software and laboratory systems and ensure data integrity within those systems.
- Travel periodically between the Warrenville, Illinois, and Fayetteville, Arkansas, laboratories to maintain consistent quality practices.
- Develop, maintain, and improve PASL SOPs, quality documentation, and workflow processes.
- Lead and develop the PASL Quality team and facilitate quality-related training.
- Oversee the laboratory safety program and related procedures.
- Maintain the equipment calibration and preventive maintenance program and own data integrity and quality within PASL laboratory software and systems.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
