Quality Assurance Manager - Clinical Laboratory

Vibrant Wellness; Santa Clara (CA); Presencial; USD 110 000 - 150 000; Tempo integral

Resumo da oferta

Vibrant Wellness in Santa Clara, CA seeks a Clinical Laboratory Quality Assurance Manager to lead daily quality activities in a high‑complexity lab. You will ensure CLIA, CAP, and NYSDOH compliance and keep the lab inspection‑ready, collaborating with Regulatory QA, technical supervisors, CLS staff, and operations.

You will drive staff development, change controls, and continuous improvement while maintaining accurate documentation and a safe, compliant environment.

Qualificações

• Bachelor’s degree in Medical Technology, Clinical Laboratory Science, Biology, Chemistry, or related field; advanced degree valued.
• 5–10 years of quality assurance in a high‑complexity CLIA‑certified lab.
• Hands-on with document control, QC, proficiency testing, calibration verification, and CAPA.
• Experience supporting CAP and CLIA audits, including preparation and follow‑through.
• Knowledge of CLIA ’88 regulations, CAP checklists, and Good Laboratory Practice.

Responsabilidades

• Lead day-to-day QA activities to meet CLIA, CAP, and NYSDOH requirements; coordinate with Regulatory QA and CLS staff.
• Supervise a four-person onsite QA team; set priorities and develop staff.
• Manage document control: SOPs, Quality System Procedures, forms, and records.
• Oversee QC review and trending; investigate out-of-range results and document actions.
• Coordinate proficiency testing enrollment, review, and investigation of unacceptable results.
• Perform and review linearity, calibration verification, and correlation studies.
• Lead CAPA investigations: root cause analysis, action plans, and effectiveness checks.
• Manage competency assessments and QA training for lab staff; train on new QSPs.
• Support verification and calibration activities for new tests, method changes, and equipment updates.
• Serve as primary contact for quality issues, complaints, and external QA communications.
• Lead inspection readiness and audit preparation; assist auditors during CAP, CLIA, and NYSDOH inspections.

Conhecimentos

Quality assurance

Documentation

Audit coordination

Leadership

Regulatory knowledge

Formação académica

Bachelor's degree in Medical Technology / CLSS related field

Descrição da oferta de emprego

Role: Clinical Laboratory Quality Assurance Manager

Lead quality systems that protect accuracy, compliance, and patient trust.

Work Model: On-site

Employment Type: Full-time

Schedule: Monday–Friday, 9:00 a.m.–5:00 p.m.; evenings and weekends as needed

Salary Range: $110,000–$150,000 annually

Note: This position is not eligible for employment-based visa sponsorship now or in the future.

About Vibrant Wellness

At Vibrant Wellness, we are passionate about unraveling one of life’s greatest mysteries—human health. We explore how nutrition, environment, genetics, sleep, physical activity, infections, mood, and the gut microbiota interconnect to shape longevity and well-being.

Our vision is to understand the connections among genetics, lifestyle, and environment through testing—and to provide personalized solutions that support longevity.

Vibrant combines innovation with the scientific rigor of an academic institution. As a CLIA-certified, CAP-accredited, and NYSDOH-approved clinical laboratory, we use proprietary technology grounded in physics, chemistry, and biology to advance personalized health testing and diagnostics.

Working at Vibrant

At Vibrant, you’ll join a team that combines scientific curiosity with a commitment to improving human longevity. We believe in collaboration, creativity, and continual learning. You’ll be supported, valued, and empowered to make a meaningful impact.

Position Summary

The Clinical Laboratory Quality Assurance Manager leads the day-to-day quality activities of Vibrant’s high-complexity clinical laboratory in Santa Clara. This onsite people leader ensures that CLIA, CAP, and NYSDOH requirements are implemented consistently and that the laboratory remains inspection-ready.

The QA Manager works closely with Regulatory Quality Assurance, Technical Supervisors, Clinical Laboratory Scientists, and laboratory operations. The role also supports new-test verification and change orders, develops staff capability, and strengthens quality and safety practices so results remain accurate, reliable, and compliant.

Key Responsibilities

• Lead day-to-day QA activities that support CLIA, CAP, and NYSDOH requirements, coordinating with the Regulatory QA Manager, Technical Supervisors, CLS staff, and laboratory operations to complete commitments on time.
• Lead, coach, and coordinate the work of a four-person onsite QA team; set clear priorities, reinforce accountability, and support staff development.
• Manage document control, including the review, revision, approval, distribution, and maintenance of SOPs, Quality System Procedures, forms, and related records.
• Oversee quality control review and trending; investigate out-of-range results and ensure appropriate follow-up and documentation.
• Coordinate the proficiency testing program, including enrollment, submission, review, and investigation of unacceptable results.
• Perform and review linearity, calibration verification, and correlation studies.
• Lead CAPA investigations, including root cause analysis, action planning, documentation, and effectiveness checks.
• Manage competency assessments and quality training for laboratory staff, including training on new QSPs and quality control procedures.
• Support verification and calibration activities for new tests, method changes, equipment updates, and change orders.
• Serve as the primary contact for quality-related issues, quality complaints, and external quality communications.
• Lead inspection readiness and audit preparation; organize documentation and support auditors during CAP, CLIA, and NYSDOH inspections.
• Partner with the EHS consultant to maintain a safe, compliant laboratory and deliver required environmental health and safety training.
• Use and improve the electronic quality management system, strengthening workflows, documentation discipline, and continuous improvement practices.

Required Qualifications

• Bachelor’s degree in Medical Technology, Clinical Laboratory Science, Biology, Chemistry, or a related scientific field; an advanced degree with relevant clinical laboratory experience is also valued.
• Five to ten years of quality assurance experience in a high-complexity, CLIA-certified clinical laboratory.
• Hands-on experience with document control, quality control, proficiency testing, linearity, calibration verification, correlation studies, and CAPA.
• Experience supporting CAP and CLIA audits and inspections, including audit preparation, documentation, response, and follow-through.
• Working knowledge of CLIA ’88 regulations, CAP checklists, and Good Laboratory Practice.
• Experience leading people or coordinating the work of a quality team in a clinical laboratory environment.
• Strong analytical, organizational, documentation, and time-management skills, with exceptional attention to detail.
• Clear written and verbal communication skills; able to train staff, influence across teams, and work effectively with CLS and technical leadership.
• Ability to learn an established quality system quickly, adapt to different ways of working, and complete transitions without losing momentum or compliance.

Preferred Qualifications

• NYSDOH experience is highly preferred, including experience in a NYSDOH-approved clinical laboratory, familiarity with NYSDOH Clinical Laboratory Standards of Practice, and support for NYSDOH inspections.
• Current California Clinical Laboratory Scientist license.
• ASCP or ASQ certification, such as CQA or CMQ/OE.
• PhD in a relevant field with clinical laboratory experience.
• Experience with laboratory safety and EHS programs.
• Experience with new-test verification, electronic quality management systems, or a mass spectrometry-intensive laboratory environment.
• This role divides time between office work and hands-on activity in a biosafety level 2 clinical laboratory.
• Personal protective equipment is provided and required in the laboratory. Exposure to biological specimens and laboratory reagents is possible during laboratory activities.
• The role may support audits outside normal business hours when needed.
• The environment is fast-paced, highly collaborative, and innovation-driven, with active communication across Clinical, Research and Development, and Operations teams.
• Team members are expected to uphold Vibrant’s culture of safety, accuracy, and continuous improvement.