Years Experience: 4+ Years The CAPA Process Analyst II: 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/Client 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. They will be 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 about the needs of the business. Supports the attainment of Client 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 processes in medical devices or laboratories Excellent communication and technical writing skills Preferred Qualifications: Understanding of statistics, FMEA, and an ASQ CQE Knowledge of Quality requirements within Clinical Laboratory Improvement Amendments (CLIA), College of American Pathologists (CAP) regulations, or similar regulated industries. Benefits: •Medical, Vision, and Dental Insurance Plans •401k Retirement Fund About The Company: Our client is a globally diversified healthcare company with a central purpose of helping people live their healthiest possible lives. They offer a broad portfolio of market-leading products that align with favorable long-term healthcare trends in both developed and developing markets. Working with this company, you'll tackle a wide array of problems including some of the world's greatest healthcare challenges while experiencing myriad cultures, geographies, and technologies. They are creating the future of healthcare through life-changing technologies and products that make you healthier and stronger, quickly identify when you have a medical need, and treat conditions to help you get back to doing what you love. It serves people in more than 160 countries with leading medical devices, diagnostics, nutrition products, and branded generic medicines. If you are looking for a great company to work for, look no further because our client has received an average of a four-star rating from its thousands of employees that have written positive reviews on Glassdoor and Indeed.
