CAPA Process Analyst

Job Overview

Job Description

Title: CAPA Process Analyst II
Location: Lake Forest, IL 60045
Duration: 06 Months

Shift Timings: 8AM to 5PM

Pay range : $28/hr to $32/hr on W2

Description:
Exempt/Non-Exempt: Non-Exempt
Years Experience: 4+ Years
• Progresses investigations and other activities through the CAPA program.
• Leads cross-functional teams in the use of investigational tools to determine the root cause of nonconformities, ensures that CAPA plans address root causes, and that CA/PAs are implemented timely to facilitate the rapid and compliant introduction of new/improved products, processes, and systems.
• Ensures that actions are on time, thorough, complete, and meet the needs of the business and customers, and that required standards and/or procedural requirements are met.
• Leads a multifunctional team, ensuring that all communications, interpersonal interactions, and business behaviors are consistent with the Client Code of Conduct.

Main 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.
• Ensures effective written and verbal communications.
• 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.

Required Qualifications:
• Bachelor’s degree in engineering or Life Sciences
• Experience with Corrective and Preventative Action process in medical devices or laboratories
• Excellent communication and technical writing skills

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.