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Job Title: CAPA Analyst
Category:  Scientific (1210)
Description: 

  • The CAPA Analyst will apply the CAPA process and perform related activities and will be responsible for monitoring and analyzing data, trending and supporting activities for process improvements and systems integration projects.

  • Participate in CAPA process and system improvements

  • Collaborate with CAPA administrators/analysts across all plants

  • Participate in CAPA review meetings

  • Ensure compliance to the Divisional CAPA process requirements

  • Perform trending activities

  • Maintain and develop divisional metrics

  • Communicate CAPA data and information to management

  • Provide information, as appropriate, to feed into the corporate CAPA process

  • Support the continuous improvement initiatives

  • Participate in divisional training on systems and/or processes related to CAPA System

  • Provide guidance on CAPA System requirements and expectations

  • Actively promote a team approach to the CAPA process across all departments and all plants

Requirements: 

  • A Bachelor's Degree in Business, Engineering Science or a related field is highly preferred for this position. Relevant professional experience may be considered in lieu of education. 2-5 years of experience with Corrective Action in a regulated industry is also required.

  • Ideal candidates will also possess the following skills/experiences:



  • Applied knowledge of Quality Management System requirements: ISO 9001 / 13485 and FDA Quality System Regulation

  • Demonstrated ability to use appropriate problem solving techniques

  • Demonstrated ability to facilitate root cause investigations and analysis

  • Demonstrated ability to work with electronic systems to perform data analysis, trending and system configuration activities. Experience with TrackWise is a plus

  • Demonstrated proficiency in technical writing

  • Demonstrated results orientation, multi-tasking skills and the ability to learn quickly and work well independently

  • Demonstrated ability to prioritize and accomplish work with little supervision

  • Demonstrated ability to collaborate with a diverse group of individuals

  • Demonstrated ability to effectively manage projects, Project Management experience is a plus



  • Demonstrated ability to use MS Office, Outlook, Visio and MS Project

Location  Mahwah , NJ
Minimum Experience (yrs):  5+
Required Education:  Not Specified


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