Laboratory QA Manager: Compliance & Improvement Lead

Onterris, Inc.; Orange (CA); Hybrid; USD 80,000 - 100,000; Full time

Job summary

Onterris, Inc. in Orange, CA is seeking a QA Manager to lead quality operations at the Orange Laboratory, oversee service centers and laboratory quality systems, and ensure regulatory compliance while advising internal teams and external clients.

You will work with the QA Director to drive continuous improvement and ensure every result reflects our commitment to excellence. Travel to California service centers is expected as needed.

Qualifications

• Bachelor’s degree in a scientific discipline or related field.
• 5+ years of experience in quality assurance, regulatory compliance, or related operations.
• Working knowledge of TNI and/or ISO 17025 standards, industry regulations, 40CFR, or other regulated environments.
• Demonstrated leadership experience, including coaching and mentoring teams.
• Excellent communication, analytical, and problem-solving skills.
• Ability to manage multiple priorities and work effectively with cross-functional teams.

Responsibilities

• Lead quality governance across the business unit and ensure adherence to quality policy.
• Maintain on-site presence to support daily quality operations and audits.
• Oversee accreditation maintenance and proctor proficiency testing programs.
• Write, organize, and ensure SOPs comply with standards and accreditation.
• Implement and improve QA programs and QA manuals.
• Ensure compliance with Ethics and Data Integrity programs.
• Coach and mentor quality team members to strengthen skills.
• Manage agency and client audits and respond to audit reports.
• Provide regulatory interpretation and collaborate on corrective action processes.

Skills

Leadership

Communication

Problem solving

Analytical thinking

Education

Bachelor’s degree in a scientific discipline

Job description

Onterris, Inc. in Orange, CA is seeking a QA Manager to lead quality operations at the Orange Laboratory, oversee service centers and laboratory quality systems, and ensure regulatory compliance while advising internal teams and external clients.

You will work with the QA Director to drive continuous improvement and ensure every result reflects our commitment to excellence. Travel to California service centers is expected as needed.