ISO 17025 Quality Manager - Dual-Lab Labs

Phigenics, LLC; Fayetteville (AR); Presencial; USD 120.000 - 170.000; Tempo integral

Resumo da vaga

Phigenics LLC in Fayetteville, AR seeks a PASL Quality Manager to own and lead the Quality Management System for both laboratories, driving ISO/IEC 17025:2017 alignment and accreditation readiness.

You will manage audits, CAPA, document control, calibration programs, and data integrity in PASL software, while developing the quality team and partnering with site leadership. This role requires strong communication and cross-disciplinary coordination across chemistry and microbiology workflows.

Qualificações

• Bachelor's degree in Chemistry, Microbiology, Biology or related field
• Minimum 5 years of laboratory quality experience with ISO/IEC 17025
• Experience as Quality Manager or ISO/IEC 17025 lead
• ISO/IEC 17025 Internal Auditor training preferred; ASQ CQA or equivalent a plus
• Demonstrated experience leading internal and external audits, CAPA programs, and management review processes
• Knowledge of measurement uncertainty, method validation/verification, and proficiency testing

Responsabilidades

• Own and continually improve the PASL Quality Management System in conformance with ISO/IEC 17025:2017, TNI Standard 2016, and internal/external standards
• Serve as PASL's primary contact with accrediting bodies for accreditation matters
• Plan and execute the annual internal audit program across both PASL locations; lead external audits
• Lead the CAPA process with root-cause analysis, effectiveness verification, and timely closure
• Own the management review process, compiling quality metrics and trends for leadership
• Oversee document control for the quality manual, SOPs, forms, and records across departments
• Direct calibration and preventive maintenance program ensuring metrological traceability
• Oversee measurement uncertainty and proficiency testing programs
• Design, administer, and evaluate the PT/interlaboratory program; resolve PT issues
• Recruit, train, mentor PASL quality staff; ensure competency assessments
• Maintain and review PASL Safety Manual and Safety Program with Phigenics team
• Maintain PASL software knowledge (LIMS etc.) and data integrity
• Travel between Warrenville, IL and Fayetteville, AR as needed to align practices

Conhecimentos

Quality management

Audits

CAPA management

Leadership

Policy & procedure writing

Time management

Communication

Team player

Formação

Bachelor's degree in Chemistry, Microbiology, Biology

ISO/IEC 17025 Internal Auditor training

ASQ Certified Quality Auditor (CQA) or equivalent

Ferramentas

ATL Titan LIMS

Bio-Rad CFX Manager

EndoScan-V

FedEx Ship Manager

Descrição da vaga

Phigenics LLC in Fayetteville, AR seeks a PASL Quality Manager to own and lead the Quality Management System for both laboratories, driving ISO/IEC 17025:2017 alignment and accreditation readiness.

You will manage audits, CAPA, document control, calibration programs, and data integrity in PASL software, while developing the quality team and partnering with site leadership. This role requires strong communication and cross-disciplinary coordination across chemistry and microbiology workflows.