Johnson & Johnson is currently seeking a QA Specialist CSV to join our Johnson & Johnson Innovative Medicine Supply Chain organization located in Wilson, North Carolina.

While this role will ultimately support the site operations located in Wilson NC, this role will also be required to support the project phase across both design & construction. For the project design phase, the role will require you to be present with our design teams in the Greater Philadelphia region. Once the design phase is completed, this role will support the construction and operational start-up of the site. For this, you will be required to be on site in Wilson, NC. Based on your current location the hiring team will work with you to determine travel and relocation arrangements. In steady state, we expect travel to be less than 10%.

• Participate in all qualification's implementation of computerized and noncomputerized systems to follow the proper life cycle phases of a project including Concept, Planning, Requirements, Design, Construction, Testing and Maintenance.
• Works with the applicable qualification teams representing Quality Assurance in the requirement, design review, construction, qualification and leveraging documentation strategies, cleaning development/validation and implementation of projects to ensure quality, regulatory, engineering, safety, and process requirements for new technology; existing and site equipment/systems are properly met.
• Ensure all requirements are properly traced, tested, and qualified across the life cycle of the project and the facilities, utilities, systems, and process train are properly released for further cleaning and process validation.
• Review and approve: URS, FRS, HDS, SDS, Unit Integration Testing, FAT, SAT, IQ, OQ, PQ, Risk Assessment, TM, Deviations, Code Reviews, Release Notifications and Master Plans, as needed.
• Evaluate and determine the potential impact of a process change affecting the quality and/or cost of related products.
• Evaluate, review, and approve equipment / systems related to CAPA's until their closure.
• Support upgrades, modifications, or changes to GxP Systems components from the quality and compliance perspective and based on 21 CFR Part 11 assessments.
• Report and escalate quality risks/issues to the Quality Leadership team; assure implementation of lessons learned and best practices from other internal or external projects regarding quality.
• Provide consulting to project management team for new systems, to ensure appropriate internal quality systems are in place.
• Responsible for the evaluation, review and approval of all the plant CSV life cycle documentation and test results (existing and new systems) for compliance with Good Software Engineering and regulatory standards including change requests, SOP's, Work Instructions, validation protocols, reports and any other technical document.
• Ensure all computerized and analytical systems maintain their validated state by performing annually periodic review and revalidation as necessary.
• Ensure all Deviations, exceptions are properly described, detail, evaluated, preapproved, impacted document update and action plan closed across the project testing phases.
• Train required personnel in Computerized Systems Operations and Maintenance.
• Develop procedures and qualification documents related to Computerized Systems and Validation of QA systems when they are required.

• A Bachelor's degree in a scientific or engineering discipline.
• A minimum of 4 years' relevant experience working within the biological and/or pharmaceutical industry.
• Strong knowledge in compliance with Computerized Systems, Software Development Life Cycle (SDLC), and qualification of facilities, utilities, equipment, and laboratory practices (GALP).
• Extensive knowledge of US and International Computerized Regulatory Requirements, with experience in Pharmaceutical Manufacturers Association (PMA) SDLC methodology or ISPE GAMP 5, GALP, and GLP.
• Strong interpersonal and conflict management skills, with the ability to manage complexity.
• Strong decision-making and problem-solving skills, with the ability to influence others regarding quality goals.
• Strong project management skills.
• High integrity and commitment to operating ethically within regulatory requirements.
• Self-empowered professional capable of making pragmatic, well-motivated decisions independently.
• Excellent communication and interpersonal skills, able to collaborate with cross-functional teams and convey complex quality concepts to all levels.
• Strong analytical skills with experience leading investigations and implementing CAPAs.
• Proven ability to drive change and promote a culture of quality.
• Detail-oriented with a focus on process improvement.
• Ability to manage multiple priorities and work independently with minimal supervision.
• Collaborative team player, able to interact with all organizational levels.

• Experience in a supporting functional area (e.g., Manufacturing, Technical Operations, Engineering & Maintenance, R&D, etc.).
• A minimum of 3 years of experience as QA Validation in implementation of facilities, equipment and systems in Room Alarm Monitoring, HVAC, Water and Cleaning Systems, and PAT/RTR with evaluation, review and approval of all the qualification and CSV life cycle documentation, test results and compliance with good software engineering practices and regulatory standards.
• Sound Technical Writing skills.

• Vacation - up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
• Holiday pay, including Floating Holidays - up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year