The Johnson & Johnson Family of Companies is currently recruiting for a Senior Analyst Quality Computer System Validation (Q-CSV) PLM/Document Management. This role can be remote, working from home, or within any Johnson & Johnson location within the United States or Europe. Preferred location is West Chester, Pennsylvania.
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 265+ Johnson & Johnson operating companies employ approximately 126,500 people in 60 countries throughout the world.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
Quality Computerized System Validation (Q-CSV) Center of Excellence ensures compliance of systems across the enterprise in accordance with the J&J Software Development Lifecycle and Computer System Validation methodologies, assures compliance within the enterprise with applicable global regulations, advise on quality matters, and assist with closing compliance gaps related to audits and inspections.
The Sr Analyst Q-CSV PLM/Document Management 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.
Major Duties and Responsibilities
Approximate Percentage of Time -
• 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.
• Author, review, and/or approve 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 Q-CSV portfolio with the purpose of minimizing the risk of inspection observations to Business systems/infrastructure within Q-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.
• Facilitate education and training to the organization on CSV program procedures and controls.
• 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.
• 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 Q-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 Q-CSV organization.
• Ensure timely completion of assigned training and expense reports.
• An Associate’s Degree is required.
• A Bachelor’s degree in Computer Science, Information Systems, Business Administration, the Sciences or other related field is a plus; additional certifications a plus.
• A minimum of 3-5 years of progressive experience in the pharmaceutical/med device/biotech industry, with direct experience in Computerized System Validation activities
• Experience in authoring or approving 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 in the pharmaceutical/med device/biotech industry is required
• Experience in Testing Management tools like HPALM is preferred
• Project Management skills is a plus
• Must have the ability to make decisions by seeking out and maintaining trusting and collaborative relationships to meet business needs and demands
• Must have the ability to work effectively in a highly matrixed team environment
• 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 required
• Working knowledge of Global regulations like Annex 11 is preferred
• Validation experience with implementing PLM systems and other systems like LIMS, CAPA, MES, SAP, LMS, Complaints Handling, and Change Control
• Superior written and oral communication and excellent Microsoft Office skills are required
• 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
• Must have the ability to independently determine and develop approach to solutions and may determine long-term solution
• Ability to manage multiple and competing projects as required