Johnson & Johnson Careers

Senior Analyst, JJ Technology Quality - Complaint Handling /Service & Repair/Event Management

Raritan, New Jersey
Validation


Job Description

Requisition ID: 1146180510

Johnson & Johnson is recruiting for a Senior Analyst, JJ Technology Quality - Complaint Handling /Service & Repair/Event Management to be located anywhere in the United States near a Johnson and Johnson 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.

 

JJ Technology Quality’s (JJTQ) 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.

You, the Senior Analyst, JJ Technology Quality - Complaint Handling/Service & Repair/Event Management is responsible for supporting the project team through the day to day project activities under the supervision and direction of the Manager. The purpose of this role is to assist and work closely with the Project Manager for project planning and execution activities.

You, Senior Analyst, JJ Technology Quality - Complaint Handling /Service & Repair/Event Management will:

  • Be 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.
  • Support internal and external Health Authority regulatory audits.
  • Be responsible for the approval of SDLC validation documentation deliverables including the approval to release system implementation and/or changes for production use.
  • Be responsible for providing CSV guidance and support to project and/or base business support teams in the resolution of validation documentation corrections and/or test defects
  • Perform pre and post review and approval of validation test scripts including test defects Review/approval 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.
  • 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.
  • 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.
  • Demonstrate an understanding of many relevant Quality and Compliance principles and their applications.
  • Work with the JJ Technology Quality  Manager in developing, monitoring and managing project costs, schedules, resources and quality.
  • Leads and mentor a team of internal and external resources through the system lifecycle and utilizes expert knowledge regarding risk management practices.
  • Assist or drive status meetings to communicate and address project risks or issues.
  • Work collaboratively with project teams to keep them informed of project status, including any barriers.
  • Build 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.
  • Define internal standards to move the organization toward a more positive risk management posture by utilizing extensive knowledge of current and emerging best practices in risk management.
  • Proactively monitor systems and processes to ensure compliance with standard operating procedures, audit compliance and industry best practices.
  • 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 JJTQ group to ensure each function is executed in an efficient manner.
  • Ensure timely reports of status, metrics and time sheets as required by the JJTQ organization.
  • Ensure timely completion of assigned training and expense reports.


Qualifications
  • BS/BA is required.
  • A degree in Information Technology or related Technical area, such as Computer Sciences and/or Engineering is preferred.
  • A minimum of 4 - 6 years of progressive experience in the pharmaceutical/medical. device/biotech industry is required.
  • Direct experience in Computerized System Validation activities is required.
  • Experience in authoring or reviewing validation protocols, Non-conformities, Change Requests, SOPs, Validation Plans and Reports is required.
  • Strong QA analyst skills with experience in Computerized System validation in GxP environments is required.
  • Expert organizational skills are required.
  • The ability to make decisions by seeking out and maintaining trusting and collaborative relationships to meet business needs and demands is required.
  • The ability to work effectively in a highly matrixed systems environment is required.
  • Working knowledge of PMO, SDLC, GAMP 5, and ITIL frameworks is preferred.
  • Thorough knowledge of cGxP (i.e., cGMP, cGPV, cGDP, etc.) regulations related to CSV, including 21 CFR Part 11, Part 210, Part 211, Part 312, Part 803, Part 820 and European Medicines Agency Good pharmacovigilance directive 95/46/EC, Directive 2002/58/EC is required.
  • Working knowledge of Global regulations like Annex 11, ICH Guideline: Post-Approval Safety Data Management, SOX, ISO is preferred.
  • Experience in Testing Management Tools like HPALM is required.
  • Validation experience with implementing Safety Systems (e.g., ArisGlobal), Complaints Handling Systems , and other systems like Event Management, NC/CAPA, Change control, and Service and Repairs Management is preferred.
  • Superior written and oral communication and excellent Microsoft Office skills are required.
  • Knowledge of SDLC Quality Management process and Computerized System Validation principles is preferred.
  • Strong skills in interdependent partnering and influencing is preferred.
  • 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.
  • Certified Software Quality Engineer (CSQE), Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Project Management Professional (PMP) or similar are preferred
  • This position will be located anywhere in the United States near a Johnson and Johnson facility and may require up to 15% domestic and/or international travel.

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-Raritan
Other Locations
North America-United States
Organization
Johnson & Johnson Services Inc. (6090)
Job Function
Validation
Requisition ID
1146180510