QA Manager, Environmental Lab Compliance

Onterris Payroll, LLC; Orange (CA); Vor Ort; USD 80.000 - 100.000; Vollzeit

Zusammenfassung

Onterris Payroll, LLC in Orange, CA seeks an on-site QA Manager to lead all quality operations for the Orange Laboratory, ensuring regulatory compliance and driving continuous improvement. The role focuses on accreditation, proficiency testing, SOPs, training, audits, and client communications, with a strong emphasis on data integrity and safety.

The position requires 5+ years in QA/regulatory roles and a bachelor’s degree in a scientific field; travel to California service centers is expected

Qualifikationen

• 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

Aufgaben

• Lead quality governance across the business unit, ensuring all staff understand and adhere to the company's quality policy and procedures.
• Maintain consistent on-site presence to support daily quality operations.
• Ensure that laboratory accreditations are maintained and expanded, as needed.
• Oversee the Proficiency Testing program, including ordering, evaluating, and reporting samples; oversee development of effective corrective actions for any failures.
• Ensure that SOPs are well written, organized, and compliant with method and accreditation standards.
• Implement and improve the QA Program and QA Manual.
• Proactively ensure compliance to the Laboratory's Ethics and Data Integrity program.
• Monitor and enforce quality system compliance by identifying, preventing, and correcting departures from established standards.
• Oversee the Corrective Action Process, ensuring corrective actions are appropriate, effective, and fully implemented.
• Coach and mentor quality team members to strengthen technical skills, regulatory understanding, and problem-solving capabilities.
• Encourage employee participation in continuous improvement initiatives and cross-functional collaboration.
• Manage and host agency audits, client audits, and site visits; respond to audit reports.
• Prepare formal client communications, including investigation summaries and compliance letters.
• Manage, perform, and document internal audits and data assessments.
• Stay current with evolving regulatory requirements; interpret changes and recommend updates to laboratory policies and procedures.
• Oversee the QA-related training program; develop and deliver departmental and corporate training to meet compliance expectations.
• Oversee the personnel training program; ensure that demonstrations of capability are documented and retained.
• Partner with the Continuous Improvement Manager, Technical Directors, Operations Managers, Lab Director and clients to resolve complex quality issues, diagnose systemic issues, negotiate compliance-appropriate solutions and provide regulatory interpretation.
• Partner with Technical Directors and Operations Managers.
• Conduct all work in a safe, efficient manner aligned with company safety standards; complying with the Laboratory's Health and Safety Plan.
• Travel to the service centers within California, as necessary.
• Perform additional duties as assigned by senior leadership.

Kenntnisse

Quality Assurance

Regulatory Compliance

Leadership

Communication

Analytical Skills

Cross-functional Collaboration

Prioritization

Safety Compliance

Ausbildung

Bachelor's degree in a scientific discipline or related field

Jobbeschreibung

Onterris Payroll, LLC in Orange, CA seeks an on-site QA Manager to lead all quality operations for the Orange Laboratory, ensuring regulatory compliance and driving continuous improvement. The role focuses on accreditation, proficiency testing, SOPs, training, audits, and client communications, with a strong emphasis on data integrity and safety.

The position requires 5+ years in QA/regulatory roles and a bachelor’s degree in a scientific field; travel to California service centers is expected