CAPA Specialist

Mahwah, NJ
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Type: Contract

Category: Engineering

Compensation Range: 40.00 - 45.00 Per Hour

Job ID: 142116

Date Posted: 06/14/2019


SUMMARY

  • Ensure compliance to CAPA processes and procedures
  • Have responsibility for review and approval of NC and CAPAs, with attention to detail, review for completeness, accuracy, effectivity and timeliness
  • Liaise with relevant functional groups, facilitate and guide 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
  • Exhibit ability to build expertise in facilitating NC & CAPA teams in the application of problem solving techniques and promote its use and development e.g. Human Error Reduction, 4-D etc.
  • Highly proficient on NC/ CAPA procedures, and super user of eCAPA system
  • Execute the NC/CAPA Review board forums
  • Monitor site NC/CAPA KPIs including reporting requirements, provide detailed updates and information in support of quality & business review forums, ensure compliance to global requirements & metrics are achieved
  • Identify continuous improvement and collaboration opportunities
  • Participate in cross-plant and corporate project teams in areas of NC & CAPA
  • Coordinate in preparation, participate and follow up to Internal, Corporate and third party compliance audits

 

QUALIFICATIONS

  • BS degree in relevant engineering discipline
  • 2+ years of experience in a similar role
  • Medical Device industry experience preferred

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