Job Overview:

The Laboratory Quality Assurance Manager is responsible for implementation of the Phase Scientific Quality Management system and ensuring compliance with all regulatory standards based on CLIA, CAP and State of California regulatory requirements. Reporting directly to the General Manager, the Quality Manager will work closely with the senior/executive team while establishing the core QA plan and regulatory compliance environment for the CLIA Laboratory in Irvine, and ensures operational, regulatory and compliance outreach and communication for Phase Scientific America.

Responsibilities:

Responsible for creating and maintaining the Quality Plan and Quality Management System (QMS) that is compliant with CLIA, CAP, NYSDOH, and FDA (whenever applicable) guidance and standards.
Provide QA expertise to the laboratory and as needed, resource for laboratory regulatory requirements and serve as the liaison to external governing and accrediting agencies.
Ensure that the laboratory and staff follow all laws and regulations required by CLIA, CAP, OSHA and NYSDOH, and any other applicable legislative organizations, and raise any related issues to upper management in real-time.
Work with other stakeholders to integrate and maintain an efficient QMS, provide all needed training and make the organization inspection ready.
Work with the Laboratory Director and department leaders to optimize and enforce the Quality Plan as it is written.
Monitor and evaluate quality activities and identify risk areas through application and integration of Lean management practices. Develop and monitor quality metrics and key performance indicators (KPI) in the laboratory.
Host Quality Meetings and Lead the Quality Management Review and implementation of quality initiatives.
Maintain a state of readiness for inspections, through regular periodic meetings with department leaders, proactive observation.
Work with the Laboratory Management to develop and lead an internal auditing process. Monitor internal audit results to identify issues and trends, ensure documentation and quality assessment of laboratory functions.
Ensure that quality standards are being met and that any deviation from an applicable protocol, standard, or guideline has been adequately investigated and addressed.
Work with lab management to address issues of non-compliance and to identify and implement necessary improvements. Support the Lab Team to implement and monitor corrective and preventive actions (CAPA).
Manage all laboratory certifications including timelines for applications and renewals.
Implement system to monitor and oversee all clinical laboratory staff certifications, training, and competency requirements.
Assist the Lab Director and Human Resources to ensure that appropriate personnel are hired for the delegated duties and CLIA designations. Maintain CLIA personnel records.
Work with the Laboratory Director to coordinate testing, monitoring, and documentation of proficiency testing.
Manage the Document Control System. Perform quality review and approval of laboratory procedures, technical protocols, reports within online document system. Monitor and oversee document periodic reviews.
Develop and implement a quality strategic plan for the Quality Management System (QMS) to successfully support lab-developed tests (LDT) and FDA-approved IVD medical devices including software algorithms intended to provide patient information, as applicable.
Approves assay verification and validation protocols and reports. Provides guidance on regulatory requirements for verifications and validation procedures.
Work with the Laboratory Management to ensure equipment, standard operating procedures, and methods meet regulatory requirements before testing human specimens.
Work with staff to document regulatory compliance and use data collection tools to assess compliance with regulatory and accrediting agency standards.

Safety:

Work with the Laboratory Safety Personnel to provide guidance and direction to ensure that overall safety and security standards are followed and amended in response to federal and state regulations, audits, or other directives.
Work with the Laboratory Safety Personnel to maintain documentation and assist with implementation of staff hiring, education, including safety and security, follow-up of incident reports/corrective action reports, and quality assurance.
Work with the Laboratory Safety Personnel to coordinate and lead Laboratory Safety Committee meetings with section staff, ensuring that safety issues are discussed and addressed properly.
Work with the Laboratory Safety Personnel to conduct safety audits and documentation.

Operational:

Must work safely in the presence of human specimens including blood, urine, and other clinical samples, body fluids or tissues.
May be exposed to infectious agents or toxic laboratory chemicals.
May travel outside the laboratory for training purposes or for job-related meetings.
Must comply with all state and federal COVID-19 regulations.

Qualifications:

Bachelor’s degree in clinical laboratory science, medical technology, biology, microbiology, molecular biology, chemistry or a related field from an accredited college or university.
5-7 years of experience in QA/QC with progressive experience, life science is a plus
At least two years of recent experience in a quality assurance role in a CLIA laboratory with detailed knowledge of and experience with implementing quality management system that is compliant with CLIA, CAP and all state and national regulatory requirements.
Experience in laboratory safety, regulatory compliance, and project management.
Quality Improvement, Lean, and/or Six Sigma training and Certification.
Quality Professional Certification.
Ability to write business correspondence and standard operating procedures.
Ability to speak clearly and persuasively to effectively present information and respond to questions from both technical and non-technical staff, auditors, and inspectors.
Proficiency with Microsoft Office programs, online document management systems, Laboratory Management systems (LIMS)
Ability to work under pressure and handle multiple and changing priorities.
Ability to think and respond quickly and efficiently in a fast-paced environment.
Ability to plan and organize work.

Benefits:

Competitive salary + 16% Bonus Structure
Hybrid Work Schedule
Health Insurance
Vision Insurance
Dental Insurance
401k - 4% Match

PHASE Scientific Americas

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Quality Assurance Laboratory Manager