Johnson & Johnson Careers

Quality Technology Analyst, Governance and Operations

Piscataway, New Jersey
Validation


Job Description

Requisition ID: 9860180131

Johnson & Johnson is recruiting for a Quality Technology Analyst, Governance and Operations and can be location in Piscataway, NJ.

Johnson & Johnson Family of Companies, 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.

With $74.3 billion in 2014 sales, Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services for the consumer, pharmaceutical, and medical devices and diagnostics markets. The more than 250 Johnson & Johnson operating companies employ approximately 119,000 people in 60 countries throughout the world.

You, the Quality Technology Analyst, Governance and Operations will:

Technology Quality ensures compliance of systems across the enterprise in accordance with J&J Policies and Procedures including SDLC and CSV Framework procedures. 

The Analyst, Technology Quality Governance and Operations is responsible for: 
  • Assignment of CSV framework training for the enterprise
  • Provide training metrics/information
  • Supporting CSV tools, including UAT test execution
  • Supporting the System Inventory activities for Technology Quality organization
  • Resource on and offboarding for the Technology Quality organization 
  • Support the charge back and financial models for Technology Quality organization 
  • Supporting the framework, policies and procedures for Computer System Validation aspects of the IT Quality System
  • Responsible for Technology Quality Resource Management including onboarding and offboarding of resources
  • Responsible for supporting the training assignment for new and changed resources for CSV SOPs
  • Support the enhancement of tools used for managing the Technology Quality organization
  • Support the maintenance of the System Inventory for Technology Quality supported systems
  • Support intake, resource and finance follow up to support the PMO function
  • Support for Portfolio Management for the Technology Quality supported systems
  • Support the Risk Based CSV framework processes 
  • Support the performance and health of the Technology Quality organization through metrics and analytics
  • Work with various SMEs to obtain needed information to complete above deliverables
  • Works collaboratively with project team members to support deliverables for the Governance and Operations function
  • Builds and maintains trusting, collaborative relationships and partnerships with internal and external stakeholders which help accomplish key business objectives, and helps others to do the same
  • Utilizes knowledge of relevant principles to recommend existing solutions 
  • Appropriately escalates any potential or perceived risks
  • Provide an environment which encourages the company's credo and diversity of opinions and thoughts
  • Ensure timely completion of assigned training and expense reporting
  • Develop and maintain an effective working partnership with senior management
  • Collaborate with other leaders and staff within Technology Quality group to ensure each function is executed in an efficient manner
  • Ensure timely reports of status, metrics and time sheets as required by the Technology Quality organization
  • Ensure timely completion of assigned training and expense reports
  • Perform other work-related duties as assigned

Qualifications
  • BS/BA is required a concentration in Information Technology or related Technical area, such as Computer Sciences and/or Engineering is preferred
  • 2-4 years of experience or an MS with 0 years of experience or 2 relevant internships and 0 years of experience is required
  • Strong skills in Microsoft applications (MS Office, Excel, PowerPoint, and Outlook) is required.
  • An advanced knowledge and use of Microsoft Excel (macros, pivot tables, vlookups, etc.) for data analysis is required
  • Working knowledge of PMO, SDLC, GAMP 5, and ITIL frameworks is highly desirable
  • Thorough knowledge of cGMP regulations related to CSV, including 21 CFR Part 11, Part 210, Part 211 and Part 820 is preferred
  • Strong organizational and technical writing skills required
  • Detail oriented, but focused on efficiency and workable solutions
  • Ability to work independently with only high-level guidance and supervision
  • Experience in System design, deployment and validation/qualification is a plus
  • Experience working in an FDA regulated environment with high emphasis on Validation/Qualification & Compliance of systems and processes is a plus
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today. 

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

Primary Location
United States-New Jersey-Piscataway
Organization
Johnson & Johnson Services Inc. (6090)
Job Function
Validation
Requisition ID
9860180131