Onsite Clinical Lab QA Lead – Compliance & Quality

Vibrant Wellness; Santa Clara (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Quality assurance

Documentation

Audit coordination

Leadership

Regulatory knowledge

Education

Bachelor's degree in Medical Technology / CLSS related field

Job description

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.