Lead Laboratory QA & Compliance Manager

OMIC USA Inc.; Portland (OR); On-site; USD 90,000 - 130,000; Full time

Job summary

OMIC USA, Inc. in Oregon seeks a Quality Assurance Manager to verify quality control policies and regulatory compliance in the laboratory.

You will lead the Quality Assurance Unit, coordinate the Quality Management System, and drive continual improvements with cross‑functional teams. The role requires a Bachelor's degree in chemistry or a related science, plus 2 years of QA/regulatory experience, ideally with ISO 17025, NELAC, or GLP experience.

Qualifications

• Bachelor's degree in Chemistry or a relevant science; 2 years QA/regulatory experience preferred.
• Experience with ISO 17025, GLP, NELAC or equivalent regulatory frameworks.

Responsibilities

• Be a proactive leader; identify opportunities and foster a culture of continual improvement of quality and procedures in the laboratory.
• Coordinate and maintain the laboratory’s Quality Management System with support from the Laboratory Director, Laboratory Manager, Group leaders, and laboratory staff including: Document Control and Quality Records, Training Documentation, Internal and External Audits, Corrective & preventative actions, and continuous improvement.
• Proficiency testing; scheduling, reporting & follow up; Supplier qualification, and traceability; Archivist for GLP study specific records.
• Prepare special reports to regulatory agencies and/or clients; verify new method validations and improvements; write and maintain quality management system SOPs and documentation in collaboration with QAU, Laboratory Manager, Director, and others.
• Coordinate Annual Quality Review Meetings with Laboratory Management; manage calibration verification/maintenance of lab equipment; assist with sales and marketing on QA inquiries.
• Coordinate and conduct laboratory meetings and QA training for staff; supervise QA Associate/Assistant.

Skills

Quality Assurance

Regulatory compliance

Leadership

Analytical skills

MS Office

Interpersonal skills

Problem-solving

Education

Bachelor's degree in Chemistry or relevant science

Job description

OMIC USA, Inc. in Oregon seeks a Quality Assurance Manager to verify quality control policies and regulatory compliance in the laboratory.

You will lead the Quality Assurance Unit, coordinate the Quality Management System, and drive continual improvements with cross‑functional teams. The role requires a Bachelor's degree in chemistry or a related science, plus 2 years of QA/regulatory experience, ideally with ISO 17025, NELAC, or GLP experience.