Current jobs related to Laboratory Quality Assurance Leader - Irvine, California - PHASE Scientific Americas
-
Quality Assurance Manager
1 week ago
Irvine, California, United States Staffosaurus Full timeAbout the JobWe are seeking a highly skilled Quality Assurance Manager to oversee our Quality Management System. The ideal candidate will have a strong background in quality assurance and a proven track record of ensuring compliance with regulatory requirements.Key ResponsibilitiesOversee the Quality Management System to ensure compliance with regulatory...
-
Quality Assurance Specialist
3 days ago
Irvine, California, United States Innova Solutions Full timeJob Summary: We are seeking a skilled Quality Assurance Inspector to join our team at Innova Solutions. As a Quality Assurance Inspector, you will be responsible for ensuring the quality of our products by performing complex work and rework at the unit and component level.Key Responsibilities:Perform final inspection duties in accordance with drawings, EOs,...
-
Quality Assurance Manager
2 weeks ago
Irvine, California, United States Youtheory Full timeJob Title: Quality Control ManagerJoin Nutrawise Health & Beauty, a leading manufacturer of health and wellness supplements, in Irvine, California. As a Quality Control Manager, you will play a crucial role in ensuring the quality and safety of our products.Job Summary:We are seeking a highly skilled and experienced Quality Control Manager to join our team....
-
Quality Assurance Manager
2 weeks ago
Irvine, California, United States Youtheory Full timeJob SummaryNutrawise Health & Beauty, a leading manufacturer of health and wellness supplements, is seeking a highly skilled Quality Control Manager to join its Irvine, California-based team. As a key member of the Quality Assurance department, you will be responsible for ensuring the quality and compliance of our products, from raw materials to finished...
-
Quality Assurance Specialist
7 days ago
Irvine, California, United States Cypress HCM Full timeJob DescriptionCypress HCM is seeking a skilled Quality Assurance Specialist to join our team. In this role, you will be responsible for operating, maintaining, calibrating, and troubleshooting clinical diagnostic laboratory instruments.Key Responsibilities:Operate and maintain clinical diagnostic laboratory instruments to ensure accurate and reliable test...
-
Quality Assurance Specialist
1 week ago
Irvine, California, United States Radiant Systems Inc Full timeJob Summary:We are seeking a highly skilled Quality Assurance Specialist to join our team at Radiant Systems Inc. As a Quality Assurance Specialist, you will be responsible for supporting in-process testing of raw materials, intermediates, and Client Controls.Key Responsibilities:Operate, maintain, calibrate, and troubleshoot clinical diagnostic laboratory...
-
Quality Assurance Specialist
2 weeks ago
Irvine, California, United States Innova Solutions Full timeJob Title: Quality InspectorWe are seeking a highly skilled Quality Inspector to join our team at Innova Solutions. As a Quality Inspector, you will be responsible for ensuring the quality of our products and services.Job Summary:The Quality Inspector will be responsible for conducting complex work and rework at the unit and component level, choosing and...
-
Clinical Laboratory Specialist
3 days ago
Irvine, California, United States TCWGlobal Full timeJob Summary:The Quality Control Clinical Laboratory Specialist position supports the testing and documentation needs of the Quality Control Department during the manufacture and release of company control products.Key Responsibilities:Operate, maintain, and troubleshoot QC Laboratory instrumentationFollow performing good laboratory practices and...
-
Clinical Laboratory Specialist
4 days ago
Irvine, California, United States TCWGlobal Full timeThe Quality Control Clinical Laboratory Specialist position supports the testing and documentation needs of the Quality Control Department during the manufacture and release of company control products.This role will work both independently and in a team-oriented environment to operate, maintain, and troubleshoot QC Laboratory instrumentation, follow good...
-
Quality Assurance Specialist
2 weeks ago
Irvine, California, United States Innova Solutions Full timeJob DescriptionInnova Solutions is seeking a Quality Inspector to join our team. As a Quality Inspector, you will be responsible for ensuring the quality of our products by inspecting components, assemblies, and laboratory test setups. You will also be responsible for identifying and resolving quality issues, and implementing continuous improvement...
-
Senior Quality Assurance Engineer
1 week ago
Irvine, California, United States Glidewell Full timeJob Title: Senior Quality Assurance EngineerGlidewell Laboratories is seeking a highly skilled Senior Quality Assurance Engineer to join our team. As a key member of our quality team, you will be responsible for leading the implementation of our Software Quality Management System (QMS) in conformance with US FDA Quality System Regulations and ISO 13485...
-
Quality Assurance Engineering Manager
2 weeks ago
Irvine, California, United States Prismatik Full timeJob Title: Quality Assurance Engineering ManagerPrismatik is seeking a highly skilled Quality Assurance Engineering Manager to lead our quality assurance team. As a key member of our organization, you will be responsible for ensuring that our products meet customer requirements and comply with US and international regulations.Key Responsibilities:Develop and...
-
Quality Assurance Specialist
2 weeks ago
Irvine, California, United States Aerotek Full timeJob Title:Quality Assurance SpecialistJob DescriptionEssential Duties and Responsibilities:Assist in developing and implementing quality programs, projects, and processes to meet ISO9001 and other relevant quality standards.Conduct internal audits and assist with certification audits, customer audits, and inspections.Review and maintain quality procedures,...
-
Quality Assurance Specialist
1 month ago
Irvine, California, United States Parker Hannifin Corporation Full timeJob SummaryThe Quality Inspector III plays a crucial role in ensuring the quality and reliability of complex components, parts, and products. This position requires a high level of expertise in quality assurance and the ability to work independently with minimal supervision.Key ResponsibilitiesConduct complex examinations and quality control inspections on...
-
Quality Assurance Specialist
2 weeks ago
Irvine, California, United States Parker Hannifin Corporation Full timeJob SummaryThe Quality Inspector III plays a crucial role in ensuring the quality and reliability of complex components, parts, and products. This position requires a high level of expertise in quality assurance and the ability to work independently with minimal supervision.Key ResponsibilitiesConduct complex examinations and quality control inspections on...
-
Quality Assurance Associate II
2 weeks ago
Irvine, California, United States Seegene USA Full time{"title": "Quality Assurance Associate II", "description": "Job SummarySeegene USA, Inc. is a global leader in molecular diagnostics, and we are seeking a highly skilled Quality Assurance Associate II to join our team. As a Quality Assurance Associate II, you will play a critical role in ensuring the quality of our products and services, and contributing to...
-
Quality Assurance and Compliance Manager
4 days ago
Irvine, California, United States Mitsubishi Chemical Carbon Fiber and Composites, Inc Full timeMitsubishi Chemical Carbon Fiber and Composites, Inc.Quality Assurance and Compliance ManagerWe are seeking a highly skilled Quality Assurance and Compliance Manager to join our team at Mitsubishi Chemical Carbon Fiber and Composites, Inc. The successful candidate will be responsible for establishing and maintaining an effective Quality Assurance (QA)...
-
Senior Software Quality Assurance Engineer
1 month ago
Irvine, California, United States Glidewell Full timeJob Title: Senior Software Quality Assurance EngineerGlidewell Laboratories is seeking a highly skilled Senior Software Quality Assurance Engineer to join our team. As a key member of our software development team, you will be responsible for ensuring the quality and reliability of our software products.Key Responsibilities:Lead the implementation of...
-
Quality Assurance Specialist
2 weeks ago
Irvine, California, United States Search Masters, Inc Full timeJob SummarySearch Masters, Inc is seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our quality management team, you will be responsible for assisting the quality manager in creating, maintaining, and distributing documentation in accordance with our quality management system: ISO9001.Key Responsibilities:Plan,...
-
Quality Assurance Specialist
1 week ago
Irvine, California, United States TCWGlobal Full timeJob OverviewOur client, a global leader in life science research and healthcare, is seeking a Quality Assurance Specialist to support the compilation and maintenance of IVDR technical files. The successful candidate will review and process labeling and FOC change requests, compile and create quality-related technical file documentations, and perform various...
Laboratory Quality Assurance Leader
2 months ago
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 relevant regulatory standards, 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 framework and maintain a compliant operational environment 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.
- Provide expert QA guidance to laboratory staff and serve as the primary contact for regulatory compliance with external agencies.
- Ensure compliance with all applicable laws and regulations, addressing any issues promptly with upper management.
- Collaborate with stakeholders to maintain an efficient QMS, delivering necessary training to ensure inspection readiness.
- Partner with the Laboratory Director and departmental leaders to refine and enforce the Quality Plan.
- Monitor quality activities, identifying risk areas through Lean management practices, and develop quality metrics and KPIs.
- Facilitate Quality Meetings and lead the Quality Management Review process, implementing quality initiatives.
- Maintain readiness for inspections through regular meetings and proactive oversight.
- Oversee the internal auditing process, analyzing results to identify trends and ensure quality documentation.
- Address non-compliance issues with lab management, implementing corrective and preventive actions (CAPA).
- Manage laboratory certifications, ensuring timely applications and renewals.
- Implement systems to monitor clinical laboratory staff certifications and training requirements.
- Assist in the hiring process to ensure qualified personnel are appointed for designated duties.
- Coordinate proficiency testing with the Laboratory Director.
- Oversee the Document Control System, ensuring quality review and approval of laboratory procedures.
- Develop a strategic quality plan for the QMS to support lab-developed tests and FDA-approved devices.
- Review and approve assay verification and validation protocols, providing regulatory guidance.
- Ensure that laboratory equipment and procedures meet regulatory standards prior to testing.
- Document regulatory compliance and utilize data collection tools for assessment.
Safety Responsibilities:
- Collaborate with Laboratory Safety Personnel to uphold safety and security standards in compliance with regulations.
- Assist in maintaining documentation related to staff education and incident reporting.
- Lead Laboratory Safety Committee meetings to address safety concerns.
- Conduct safety audits and maintain relevant documentation.
Operational Considerations:
- Adhere to safety protocols when handling human specimens and potentially hazardous materials.
- Be prepared for potential exposure to infectious agents or toxic substances.
- Travel may be required for training or job-related meetings.
- Comply with all applicable COVID-19 regulations.
Qualifications:
- Bachelor's degree in clinical laboratory science, medical technology, or a related field from an accredited institution.
- 5-7 years of progressive experience in QA/QC, preferably in life sciences.
- Minimum of two years in a quality assurance role within a CLIA laboratory, with a strong understanding of quality management systems.
- Experience in laboratory safety, regulatory compliance, and project management.
- Certification in Quality Improvement, Lean, or Six Sigma is preferred.
- Quality Professional Certification is advantageous.
- Strong written and verbal communication skills.
- Proficiency in Microsoft Office and laboratory management systems.
- Ability to manage multiple priorities and work effectively under pressure.
- Strong organizational and planning skills.
