QA Specialist CSV

QA Specialist CSV – 2406205421W

Description

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%.

J&J is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for patients. The new facility will expand production of innovative biologic medicines in areas including oncology, immunology, and neuroscience. J&Js significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the worlds most pressing healthcare challenges.

We know that the success of our business and our ability to deliver meaningful solutions depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

As the Project System Users, you will be responsible for ensuring all qualification implementation computerized and noncomputerized systems follow the proper life cycle phases with current Good Manufacturing Practices, Johnson & Johnson Policies and internal procedures to ensure compliance with regulatory requirements and industry standards.

Key Responsibilities:

Participate in all qualifications 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 CAPAs 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, SOPs, 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.

Qualifications

Required:

A Bachelors 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.

Preferred:

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.

This job posting is anticipated to close on 10/20/2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

Employees may be eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

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

Additional information can be found through the link below.

For additional general information on Company benefits, please go to: – https://www.careers.jnj.com/employee-benefits

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

Primary Location NA-US-North Carolina-Wilson

Other Locations NA-US-North Carolina-Raleigh, NA-US-North Carolina-Goldsboro, NA-US-Pennsylvania-Horsham, NA-US-Pennsylvania-Philadelphia, NA-US-North Carolina-Greenville, NA-US-North Carolina-Rocky Mount

Organization Janssen Biotech, Inc. (6014)

Relocation Eligible: Yes – Within Country

Job Function Quality Documentation

Req ID: 2406205421W