What are the responsibilities and job description for the CAPA Process Analyst II position at TekOne IT Services Pvt. Ltd.?
Role: CAPA Process Analyst II
Location: Lake Forest, IL - 60045
Duration: 6 Months
Shift Timings: 8 AM to 5 PM
Responsibilities
Location: Lake Forest, IL - 60045
Duration: 6 Months
Shift Timings: 8 AM to 5 PM
Responsibilities
- Leads the investigation of complex and highly technical quality issues to ensure the timely completion of CAPA system activities raised for nonconformances, potential nonconformances, CAPAs, deviations, And/or complaint investigations.
- Is a subject matter expert on investigation and root cause analysis techniques to ensure that Root/potential causes are appropriate and implement effective actions to reduce the Occurrence/recurrence of the nonconformance.
- Maintains the effectiveness of the CAPA system records to ensure audit-readiness for internal and external quality system audits within the area.
- Ensures all CAPA-related documentation is managed in a complete, clear, concise, and controlled Manner.
- Produces trending metrics and reports to identify, prioritize and manage further actions, as may be required.
- Provides leadership for the initiation of improvement activities associated with identified trends.
- Is an active leader supporting a work environment that ensures team effectiveness by demonstrating
- Full cross functional team support that complies with Corporate and regulatory requirements.
- Prioritizes workload in relation to the needs of the business.
- Supports the attainment of Abbott Toxicology Laboratories goals and objectives.
- Ensures compliance to organizational procedure, regulatory requirements and industry standards and
- Timely completion of CAPAs and audit findings.
