Senior CAPA Specialist from Joulé
Dunwoody, GA 30350
About the Job
Job Title: Senior CAPA Specialist
Location: Sandy Springs, GA
Hours/Schedule:
Type: Contract
Responsibilities
Requirements
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
Location: Sandy Springs, GA
Hours/Schedule:
Type: Contract
Responsibilities
- 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.
Requirements
- BS Degree in Life Sciences
- 2- 5 years of experience with CAPA processes and procedures
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
