Johnson & Johnson Careers

Senior Analyst, JJ Technology Quality - CSV Laboratory Services

West Chester, Pennsylvania
Compliance Security

Job Description

Requisition ID: 4531180227

Johnson & Johnson Family of Companies is recruiting for a Senior Analyst, JJ Technology Quality - CSV Laboratory Services in West Chester, PA or any domestic J&J facility.  

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 $70.1 billion in 2015 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 127,000 people in 60 countries throughout the world.

Position Summary:

Computerized System Validation (CSV) Center of Excellence ensures compliance of systems across the enterprise according to J&J SDLC and Quality System, assures compliance within the enterprise with applicable Federal and State regulations, advice on quality matters, and assistance for closing compliance gaps found in audits and inspections. 

The Sr Analyst, Global Quality IT - CSV Laboratory Services is responsible for:
  • Reviewing and approving validation deliverables of GxP regulated Computerized Systems to ensure full compliance with Health Authority regulatory requirements and adherence to company policies and procedures by supporting computer validation projects and base business support teams
  • Supporting internal and external Health Authority regulatory audits 
  • Responsible for the review and approval of SDLC validation documentation deliverables including the approval to release system implementation and/or changes for production use
  • Attending Project Team meetings and provide CSV compliance guidance and support to project and base business support team members.
Key Responsibilities:
  • Lead/support validation efforts and deliverables for projects requiring validation.
  • Maintain and Report the project related Metrics.
  • Perform pre- and post-review and approval of validation test scripts including test defects.
  • Review, author, and/or approve of validation documentation deliverables such as but not limited to Compliance Plans, User Requirements, System Tests, User Acceptance Tests, Traceability Matrix, and the Compliance Report including final release and approval for production use.
  • Perform CSV review and approval of Computerized System change controls including final release approval for production use.
  • Ensure a high degree of Inspection Readiness for Systems in CSV portfolio with the purpose of minimizing the risk of inspection observations to Business systems/infrastructure within CSV responsibility.
  • Participate in audits, approves audit non-conformity action plans and approve closure of internal audit findings.
  • Demonstrates an understanding of many relevant Quality and Compliance areas and their applications.
  • Proactively monitors systems and processes to ensure compliance with standard operating procedures, audit compliance and industry best practices.
  • Work with various SMEs to obtain needed information to complete above deliverables; Leads testing efforts by managing pre/post approvals and associated discrepancies.
  • Works collaboratively with project teams to keep them informed of project status, including any barriers.
  • Facilitate education and training to the organization on CSV program procedures and controls.
  • 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 Quality and Compliance principles to recommend existing solutions to organization’s needs.
  • 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 CSV group to ensure each function is executed in an efficient manner.
  • Ensure timely reports of status, metrics and time sheets as required by the CSV organization.
  • Ensure timely completion of assigned training and expense reports.

  • A Bachelor’s degree in Computer Science, Information Systems, Business Administration or other related field is required
  • A minimum of 4 years of progressive experience in the pharmaceutical/med device/biotech industry, with direct experience in Computerized System Validation activities is required.
  • Experience in authoring or approving validation protocols, Non-conformities, Change Requests, SOPs, Validation Plans and Reports is preferred.
  • Strong QA analyst skills with experience in Computerized System Validation in GxP environments in the pharmaceutical industry is required.
  • Experience in Testing Management tools like HPALM is required. 
  • Project Management skills is preferred.
  • Must have the ability to make decisions by seeking out and maintaining trusting and collaborative relationships to meet business needs and demands is required.
  • Must have the ability to work effectively in a highly matrixed team environment is required.
  • Working knowledge of PMO, SDLC, GAMP 5, and ITIL frameworks is preferred.
  • Thorough knowledge of cGMP regulations related to CSV, including 21 CFR Part 11, Part 210, Part 211 and Part 820 is required.
  • Working knowledge of Global regulations like Annex 11 is preferred.
  • Validation experience with implementing Event Management (CAPA), change control systems and other systems like LIMS, Empower, and MES Systems is preferred.
  • Superior written and oral communication and excellent Microsoft Office skills is required.
  • Knowledge of SDLC Quality Management process and Computerized System Validation principles is preferred.
  • Must have the ability to perform work with a high degree of independence in terms of self-management of a large variety of tasks and initiatives regarding Quality is required.
  • Must have the ability to independently determine and develop approach to solutions and may determine long-term solution is required.

Primary Location
United States-Pennsylvania-West Chester
Johnson & Johnson Services Inc. (6090)
Job Function
Compliance Security
Requisition ID