Role: CAPA Process Analyst

Location: Santa Rosa, CA - 95403

Duration: 12 Months

Shift Timings: 8 AM to 5 PM

Responsibilities

Led investigations into complex quality issues, including nonconformances, deviations, and customer complaints, ensuring timely and effective resolution through the CAPA system.
Acted as a subject matter expert in root cause analysis, guiding teams to identify root causes and implement corrective actions that prevented recurrence.
Maintained CAPA records to a high standard, ensuring accuracy, completeness, and audit readiness for internal and external quality audits.
Developed and analyzed quality metrics, identified trends, and prioritized corrective actions, leading data-driven improvement initiatives.
Provided leadership and direction to cross-functional teams, ensuring alignment with corporate and regulatory requirements while driving continuous improvement across quality processes.
Communicated effectively, both in writing and verbally, to ensure clarity and collaboration among stakeholders, including senior management, technical teams, and regulatory bodies.
Balanced and prioritized workload based on business needs, ensuring timely completion of CAPA actions and addressing audit findings.
Supported organizational goals within Toxicology Laboratories by ensuring compliance with regulatory requirements, quality standards, and industry best practices.

Skills

Demonstrated extensive experience in CAPA management, root cause analysis (RCA), and nonconformance investigations within a regulated industry (pharmaceuticals, medical devices, or related).
Ensured audit readiness and compliance with internal and external quality audits.
Provided leadership in cross-functional teams and successfully drove continuous improvement initiatives.
Analyzed data, trended quality metrics, and reported findings to mitigate risks and identify opportunities for improvement.
Delivered clear and concise communication in both written and verbal forms, effectively presenting complex information to diverse audiences.
Applied thorough knowledge of regulatory requirements (e.g., FDA, ISO) and quality management systems (QMS).
Managed tasks effectively, ensuring the timely completion of CAPA activities in a fast-paced environment.

Education

Preferred Qualifications

Understanding of statistics, FMEA and a ASQ CQE
Knowledge of Quality requirements within Clinical Laboratory Improvement Amendments (CLIA), College of American Pathologists (CAP) regulations or similar regulated industry.

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