Specialist, CAPA Management
Location:
Fort Washington , Pennsylvania
Posted:
March 31, 2017
Reference:
2949170223/2-en-us

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.  We are currently recruiting for a Specialist, CAPA Management, located in Horsham, PA or Fort Washington, PA.
 
 
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
 
:
 
  • Perform CAPA Management IT platform site lead duties including user access documentation & training, maintaining current user list and other duties as necessary. 
  • Provide ETS-Trackwise technical expertise for all phases of CAPA Management process including generating reports and metrics, provides troubleshooting expertise to users who experience functionality issues, interfaces with IT/technical team for process and system fixes required, performs system/user testing as needed for system upgrades.
  • Direct CAPA owners to ensure they meet the process, timelines and requirements of documenting robust root cause analyses, identifying appropriate corrective actions, and developing adequate CAPA effectiveness check plans and measures. 
  • Review and approve documented evidence provided by CAPA owners to satisfactorily close corrective action plan commitments from non-conformance investigations or audit observations. 
  • Work with CAPA record owners to communicate any deficiencies in documentation to allow for resolution in a timely manner in accordance with prescribed due dates. 
  • Accountable to quality check documented investigations and CAPAs against SOP requirements for the CAPA process and to correct or escalate issues as needed for resolution. 

Qualifications
 
Required:
  • Bachelor’s degree in technical, science, or business field (or equivalent experience), with a minimum of 3 years of experience working in pharmaceutical or other related regulated industry.
  • Demonstrated quality systems experience and good documentation practices.  Demonstrated experience in non-conformance investigation and CAPA as an investigator, contributor and/or reviewer/approver.
  • Must be able to fluently read, write, and speak English.

Preferred:

  • Knowledge of pharmacovigilance regulatory requirements and experience with safety processing, clinical study safety reporting, pharmacovigilance and medical information.
  • SOP development experience in pharmaceutical or other related regulated industry.
  • Experience supporting audits and/or inspections.
  • Project management experience.
  • Global/regional working experience (working remotely with others on business deliverables, via telephone, email and other means).
     

This position can be located in Fort Washington, PA or Horsham, PA. 

 

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.


Primary Location
United States-Pennsylvania-Horsham
Other Locations
North America-United States-Pennsylvania-Fort Washington
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Regulatory Compliance
Requisition ID
2949170223

A little about us:
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.

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