Quality System Analyst II, Document Management
Location:
Raritan , New Jersey
Posted:
December 20, 2016
Reference:
1951161129/2-en-us

Johnson & Johnson Family of Companies is currently recruiting for a Quality System Analyst II, Document Management at the preferred location of Skillman, NJ, however considerations will also be made for Raritan, NJ and Bridgewater, NJ.

 

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.


Qualifications
  • 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 Skillman, NJ, Raritan, NJ, or Bridgewater, NJ. 


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

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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