Descripción del Trabajo
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.
- Training staff on CAPA, RCA, and Technical Writing
- 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 CAPA 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
- Subject Matter Expert on all related procedures, ensuring compliance to the relevant Corporate procedures.
- 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.
- 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.
- Qualification Knowledge Skills
- Bachelor degree/ Masters of Science, Engineering or equivalent/ related subject required
- 2+ years’ experience in area of quality systems or engineering or equivalent experience.
- 4+ years in regulated environment required.
- Experience in interacting with regulatory agencies required.
- Thorough knowledge and understanding of US and International Medical Device Regulations.
- Strong knowledge of supporting Quality Systems (e.g. Audits, Management review, Quality Planning).
- Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously.
- Strong interpersonal skills.
- Strong written and oral communication and negotiations skills.
- Strong in critical thinking and "outside the box" thinking.
- Highly developed problem solving skills.
- Strong analytical skills.
- Deep understanding of statistical principles related to role
- Demonstrated ability to successfully manage and complete projects in a matrix organization.
- Demonstrated ability to work independently.
- Experience in working in a compliance risk situation.
- Demonstrated knowledge of U.S. Food and Drug regulations, as well as of European and international regulatory/industry guidelines/standards, and ability to interpret and apply.
- High level of PC skills. Must be proficient with Power BI, Minitab, Microsoft Word, Microsoft Excel and PowerPoint packages
- Some travel may be required.
The anticipated pay range for this role is $65,454 - $94,849 - $124,243. Job-related, non-discriminatory factors used to determine the actual offered rate include qualifications and experience, geographic location, education, external market data, and consideration of internal equity.
As part of the total rewards package, this position is eligible for a short-term incentive based on performance. In addition, Jabil offers benefits to enhance your health, wealth and resilient self. These include medical, dental, and vision insurance plans; 401(k) retirement plan and employee stock purpose plan; and paid time off.