Laboratory Quality Manager

Phigenics; Warrenville (IL); Presencial; USD 90.000 - 140.000; Jornada completa

Descripción de la vacante

Phigenics, LLC seeks a PASL Quality Manager to own and improve the QMS for Warrenville and Fayetteville labs. Lead audits, CAPA, and management reviews to ensure accreditation conformity and regulatory alignment.

The role requires 5+ years in laboratory quality with ISO/IEC 17025 expertise, and strong documentation and leadership skills to mentor the quality team and maintain data integrity across systems.

Formación

• Bachelor's degree in a scientific field and 5+ years quality experience in ISO/IEC 17025 labs.
• Experience leading internal and external audits, CAPA, and management reviews.
• Knowledge of measurement uncertainty, method validation/verification, and proficiency testing.

Responsabilidades

• Own and improve the PASL Quality Management System per ISO/IEC 17025 and standards.
• Serve as primary contact with accrediting bodies for audits.
• Plan and execute internal audits; support external accreditation audits.

Conocimientos

Quality leadership

Audit management

CAPA process

Documentation control

Policy & procedure development

Strong communication

Educación

Bachelor's degree in Chemistry, Microbiology, Biology

ISO/IEC 17025 Internal Auditor or Lead Assessor training preferred

ASQ Certified Quality Auditor (CQA) or similar credential a plus

Hands-on QA/QMS experience in ISO/IEC 17025 labs

Herramientas

ATL Titan LIMS

Bio-Rad CFX Manager

EndoScan-V

FedEx Ship Manager

MS Office

Descripción del empleo

Position Title: PASL Quality Manager

Reporting To: Senior Director of Operations

Location: Warrenville, IL (Phigenics Analytical Services Laboratory – PASL)

Summary

Phigenics Analytics Services Laboratory (PASL) operates two environmental testing laboratories, who perform water microbiology and chemistry testing in support of building water management programs. Both sites are accredited under TNI/NELAP and are seeking to gain ISO/IEC 17025:2017 accreditation.

The PASL Quality Manager owns and leads the Quality Management System (QMS) for both laboratories, ensuring its improvement, continued maintenance, and alignment with ISO/IEC 17025 and all applicable accreditation, regulatory, and customer requirements. As Quality Manager, this individual has the authority and freedom to identify quality issues, initiate corrective action, and ensure the integrity of laboratory operations. This role leads the accreditation program and supervises and develops the quality team.

Job Duties

• Own, implement, and continually improve the PASL Quality Management System in full conformance with ISO/IEC 17025:2017, TNI Standard 2016, and any additional internal or external standards
• Serve as PASL's primary point of contact with the accrediting body (e.g., A2LA, ANAB) for all accreditation matters, including scheduling, hosting, and responding to on-site assessments and surveillance audits
• Plan and execute the annual internal audit program across both PASL locations; lead and support the 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; ensure annual review and version control
• Direct the laboratory equipment calibration and preventive maintenance program, ensuring metrological traceability for all measurements within the scope of accreditation
• Oversee measurement uncertainty, budgets, and support method validation/verification for new or revised test methods prior to introduction into the scope of accreditation
• Design, administer, and evaluate the laboratory's proficiency testing (PT) and interlaboratory comparison program; investigate and resolve any unacceptable PT performance
• Recruit, train, mentor, and manage performance of PASL quality specialist(s); ensure staff competency assessments and quality training records are current and documented
• Maintain and review the PASL Safety Manual annually and support execution of the PASL Safety Program in partnership with the Phigenics safety team
• Maintain working knowledge of PASL software and laboratory systems (e.g., ATL Titan LIMS, Bio-Rad CFX Manager, EndoScan-V, FedEx Ship Manager) and ensure quality data integrity within these systems
• Travel periodically between the Warrenville, IL and Fayetteville, AR laboratories as needed to maintain consistent quality practices across both sites

Education and Experience

• Bachelor's degree in Chemistry, Microbiology, Biology, or a related scientific field
• Minimum of 5 years of laboratory quality experience, including direct, hands-on experience implementing and maintaining a Quality Management System under ISO/IEC 17025 (required)
• Prior experience serving as a laboratory's designated Quality Manager, or in an equivalent role under an ISO/IEC 17025 accreditation, strongly preferred
• ISO/IEC 17025 Internal Auditor or Lead Assessor training/certification preferred; ASQ Certified Quality Auditor (CQA) or similar credential a plus
• Demonstrated experience leading internal and external audits, CAPA programs, and management review processes
• Working knowledge of measurement uncertainty, method validation/verification, and proficiency testing programs
• Prior people-management experience, with the ability to train, coach, mentor, set clear expectations, and support their 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 (team player)
• Ability to work overtime occasionally, sometimes with little or no notice
• Knowledgeable in the use of computers — MS Office, LIMS and other laboratory software, and shipping programs

Accountabilities

• Safety is our first priority. No accident is acceptable
• Implement and maintain PASL's ISO/IEC 17025 accreditation and overall QMS conformance
• Ensure effective execution of internal and external audit programs and timely CAPA closure
• 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
• Own data integrity and quality within PASL's laboratory software and systems

Phigenics LLC is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, creed, color, religion, alienage or national origin, ancestry, citizenship status, age, disability or handicap, sex, marital status, veteran status, sexual orientation, arrest record, or any other characteristic protected by applicable federal, state or local laws. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.