What are the responsibilities and job description for the CAPA Process Analyst position at TekOne IT Services Pvt. Ltd.?
Role: CAPA Process Analyst
Location: Santa Rosa, CA - 95403
Duration: 12 Months
Shift Timings: 8 AM to 5 PM
Responsibilities
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.
- 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.
- Bachelor’s degree in engineering or Life Sciences.
- 2-4 years of experience.
- 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.
