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Laboratory Quality Assurance Lead

2 months ago

Irvine, California, United States PHASE Scientific Americas Full time

Position Summary:

The Laboratory Quality Assurance Manager plays a crucial role in the execution of the Quality Management System at Phase Scientific Americas, ensuring adherence to all regulatory frameworks, including CLIA, CAP, and California state regulations. This position reports directly to the General Manager and collaborates closely with the executive team to establish a robust QA strategy and compliance framework for the CLIA Laboratory.

Key Responsibilities:

  • Develop and uphold the Quality Plan and Quality Management System (QMS) in alignment with CLIA, CAP, NYSDOH, and FDA standards.
  • Serve as a QA resource for laboratory operations, liaising with external regulatory and accrediting bodies.
  • Ensure compliance with all applicable laws and regulations, addressing any compliance issues promptly with management.
  • Collaborate with stakeholders to maintain an efficient QMS, providing necessary training to ensure inspection readiness.
  • Work alongside the Laboratory Director and departmental leaders to implement and enhance the Quality Plan.
  • Evaluate quality activities and identify potential risks using Lean management practices, while developing quality metrics and KPIs.
  • Facilitate Quality Meetings and lead the Quality Management Review process, driving quality initiatives forward.
  • Maintain readiness for inspections through regular meetings and proactive oversight.
  • Develop and manage an internal auditing process, monitoring results to identify trends and ensure thorough documentation.
  • Address non-compliance issues and collaborate with lab management to implement corrective and preventive actions (CAPA).
  • Oversee laboratory certifications, ensuring timely applications and renewals.
  • Implement a system to monitor clinical laboratory staff certifications and training requirements.
  • Assist in hiring qualified personnel and maintaining CLIA personnel records.
  • Coordinate proficiency testing documentation with the Laboratory Director.
  • Manage the Document Control System, ensuring quality review and approval of laboratory procedures and protocols.
  • Develop a strategic quality plan for the QMS to support lab-developed tests (LDT) and FDA-approved IVD medical devices.
  • Approve assay verification and validation protocols, providing regulatory guidance.
  • Ensure compliance of equipment and procedures with regulatory standards prior to testing.
  • Document regulatory compliance and utilize data collection tools for compliance assessment.

Safety Responsibilities:

  • Collaborate with Laboratory Safety Personnel to ensure adherence to safety and security standards.
  • Maintain documentation related to staff hiring and safety training, including incident reports.
  • Lead Laboratory Safety Committee meetings to address safety concerns.
  • Conduct safety audits and maintain necessary documentation.

Operational Considerations:

  • Work safely with human specimens and comply with all relevant health regulations.
  • May require travel for training or job-related meetings.

Qualifications:

  • Bachelor's degree in clinical laboratory science, medical technology, or a related field.
  • 5-7 years of progressive QA/QC experience, preferably in life sciences.
  • At least two years in a quality assurance role within a CLIA laboratory, with expertise in quality management systems.
  • Experience in laboratory safety, regulatory compliance, and project management.
  • Certification in Quality Improvement, Lean, or Six Sigma is preferred.
  • Strong written and verbal communication skills.
  • Proficiency in Microsoft Office and laboratory management systems (LIMS).
  • Ability to manage multiple priorities in a fast-paced environment.
  • Strong organizational and planning skills.