The Senior Specialist, CAPA will be primarily responsible for the oversight of the CAPA process and procedures, and ensure it is compliant, effective and efficient in dealing with quality issues. The Senior Specialist, CAPA will, through expertise in problem solving methodology, facilitate proactive and effective resolution of issues. Working within the QMS team, under general supervision, ensure compliance to CAPA processes and procedures and is responsible to, but not limited to.
• Have responsibility for review and approval of NC and CAPAs, with attention to detail, review for completeness, accuracy, effectivity and timeliness. Review & Approval of CAPA changes including extension requests.
• Liaise with relevant functional groups, facilitate and mentor teams through all stages of the NC / CAPA process.
• Ensuring users provide the necessary rigor to the eCAPA system content including maintaining a live document with all relevant evidence attached, in a timely manner.
• As Problem Solving Methodology expert, facilitate and coach NC & CAPA teams in the application of problem-solving techniques and promote its use and development e.g. Human Error Reduction, 4-D etc.
• Subject Matter Expert on all related procedures, ensuring compliance to the relevant Corporate procedures. Super user of eCAPA system.
• Lead & execute the NC/CAPA Review board forums. Lead multi-site forums and participate in global forums.
• Manage & monitor site NC/CAPA KPIs including reporting requirements, provide detailed updates and information in support of quality & business review forums, also liaising with other GQO sites to ensure compliance to global requirements & metrics are achieved.
• Ensure adequate training is developed, maintained and provided to all users of CAPA process & systems.
• Identify continuous improvement and collaboration opportunities, promoting development and implementation of quality data and reports for improvement and optimization of business processes / results.
• Lead &/or participate in cross-plant and corporate project teams in areas of CAPA and quality systems improvement.
• Lead/coordinate preparation, participate and follow up to company's Internal, Corporate and third-party compliance audits.


All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county, to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.