Ensure compliance to CAPA processes and procedures.
Responsible for review and approval of NC and CAPAs, with attention to detail, review for completeness of actions and records, accuracy, effectivity, and timeliness along with the review and approval of CAPA changes and extension requests.
Liaise with relevant functional groups, facilitate and mentor teams through all stages of the NC/CAPA process.
Ensure users provide necessary rigor to the eCAPA system content including maintenance of a live record with all relevant evidence attached in a timely manner.
Facilitate and coach NC and CAPA teams in the application of problem-solving techniques and promote its uses and development (e.g. human error reduction, 4-D, 5 Why's, fishbone diagrams, process mapping, etc.)
Provide leadership to drive desired behaviors using accountability meetings and facilitate root cause analysis workshops with CAPA owners.
Act as a subject matter expert on all related procedures, ensuring compliance to the relevant procedures and serve as eCAPA super-user.
Lead and execute the NC/CAPA review board forums; may lead multi-site forums and participate in global forums.
Manage and monitor site NC/CAPA KPIs including reporting requirements, provide detailed updates and information in support of quality and business review forums, liaise with other sites to ensure compliance to global requirements and metrics are achieved.
Ensure adequate training is developed, maintained, and provided to all users of CAPA process and systems.
Identify continuous improvement and collaboration opportunities, promoting development and implementation of quality data and reports for the improvement and optimization of business processes and results.
Bachelors in a science, engineering, or related discipline.
0-2 years' experience in manufacturing or regulated industry, ideally with quality systems.
Experience in interacting with regulatory agencies highly preferred.
Strong knowledge of supporting Quality Systems (audits, management review, quality planning, etc.) highly preferred
Strong skills regarding written/oral communication, critical thinking and conflict resolution.
Experience with data analytics and visualization tools (Tableau, PowerBI, etc.) preferred.
Some travel may be required.