Quality System Analyst II, Document Management

Johnson & Johnson Family of Companies is currently recruiting for a Quality System Analyst II, Document Management to be located in Raritan, NJ or Horsham, PA. This position is part of J&J Quality Systems and Services and supports the Pharmaceutical sector.  


Caring for the world, one person at a time, has inspired and united the people of Johnson & Johnson for 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. 

The Quality System Analyst II, Document Management will:
  • Coordinate document management activities to support local and global customers.
  • Be responsible for the following daily documentation related activities: creation/edit, review, approval, effectuation, obsolescence, archival and distribution.
  • Coordinate the review and approval of GxP documents in the electronic document management system. 
  • Provide expertise to document originators, ensuring documents are created/edited per current procedures (i.e. correct template, format, content references, document properties, types of approvers). 
  • Monitor, reconcile and audit approved documents, ensuring all compliance requirements for format, content, standardization and periodic review.
  • Ensure that customer expectations are met for the quality of the final GxP document and its implementation schedule.
  • Liaise with training department to ensure document effective date does not result in adverse impact to trainees or training metrics.
  • Provide oversight/support of periodic document review process, and will run Periodic Document Review Cognos reports for Virtual Organizations and send notifications to group owners and document authors to drive timely completions.
  • Assist with reporting and analysis of biannual JSC Global Periodic Document Review metrics.
  • Serve as an electronic document management system (EDMS) super user and train new associates or document owners in document management processes and the related EDMS.

  • A combination of one of the following is required: Bachelor’s degree plus 2 years of relevant experience; Associate’s degree plus 4 years of relevant experience; High school diploma plus 6 years of relevant experience.
  • A minimum of 2 years of related experience including Quality Assurance, Quality Systems and/or Quality Control in the pharmaceutical/OTC or other highly regulated industry is required.
  • A minimum of 2 years’ experience in document management which includes use of an electronic document management system is required.
  • Knowledge of FDA/EMEA regulations and 21 CFR Part 11 requirements as well as cGMP related to documentation required.
  • Prior experience delivering training to colleagues and partners is preferred.
  • Experience providing support for internal audits and inspections by regulatory authorities is a plus.
  • This position will be located in Raritan, NJ or Horsham, PA. 

Primary Location
United States-New Jersey-Raritan
Other Locations
North America-United States-Pennsylvania-Horsham
Johnson & Johnson Services Inc. (6090)
Job Function
Quality Systems

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