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

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Gurabo, Puerto Rico, United States of America

Job Description:

Johnson & Johnson is currently recruiting for a Senior Quality Assurance Specialist, Investigation & CAPA! This position will be located in Gurabo, PR.

_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 tomorrow's breakthroughs and profoundly impact health for humanity. Learn more at _https://www.jnj.com/ .

Position Summary:

• Supports global improvements to investigation and corrective and preventive action (CAPA) process and platform across Johnson & Johnson Innovative Medicines Supply Chain (IMSC), driving excellence in NC/CAPA processes and execution.
• Works with site NC/CAPA business process owners to sustain the NC/CAPA processes in support of all IMSC sites and functions.

Key Responsibilities:

• Support an efficient and effective investigation training/certification. Support NC/CAPA system and process user training.
• Evaluates Quality Investigation and Corrective Actions and Preventive Actions (CAPA) records to monitor the overall health and quality of the IMSC NC/CAPA process execution and compliance to standards and requirements.
• Ensure that the IMSC NC/CAPA process is in an Inspection ready state and support audits/inspections as required.
• Escalate compliance issues or risks associated to the NC/CAPA process to the Senior Manager Quality Systems CAPA.
• Coordinate with IMSC sites to ensure actions are completed by responsible functions within a timely manner.
• Interface with J&J Quality Systems Platform Governance and other functions on the enhancement requests to support configurating an automating systems for investigation and CAPA Management to enable process improvements.
• Reports metrics that are indicative of the process health and overall compliance of the investigation and CAPA system.

Qualifications:

Education:

A minimum of a Bachelors or equivalent University degree is required with a focus in Chemistry, Biology, BioChemistry, Microbiology, Engineering, Mathematics or related science preferred.

Required Skills:

• A minimum of 6 years of related experience in the pharmaceutical/medical device regulated industry.
• A minimum of 6 years of experience in conducting and/or leading nonconformance and CAPA activities in a quality regulated environment and related areas in the pharmaceutical industry
• Must be able to effectively work in a highly matrixed organization, working across a global organization to support alignment.
• High degree of interdependent partnering, influencing, and team work.
• Ability to support multiple projects and priorities to remain effective and focused on business critical objectives.
• Strong collaboration and communication skills.
• High level of understanding of industry expectations for nonconformance, root cause analysis, corrective and prevent actions (end-to-end CAPA process).
• High understanding of cGMP, Good Documentation Practices, and Regulations. Familiarity with US and International GMPs for pharmaceuticals.
• Ability to apply statistical techniques to track and analyze process performance and trend
• Good analytical skills, strong problem solving and decision-making abilities.

Other:

This position may require up to 10% domestic & international travel.

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.

Push the boundaries of science to transform health—and your career.

Join us and advance life-changing treatments for people who need them most. At Johnson & Johnson, our focus is on improving global health equity and developing MedTech and pharmaceutical innovations that impact the future of health. Using AI and robotics to transform surgery or helping data scientists and clinicians formulate new ways to diagnose and treat disease, this work may sound like sci-fi, but it’s all science, all real, and could be your career. Whatever your background, skills, or career goals, there’s a place for you to help solve some of the world’s most pressing health challenges with us.

Accelerate your career while changing the world.

Each of our broadly-based family of companies offers an inclusive and empowering culture and employee benefits (like paid time off to volunteer, transgender-inclusive and same-sex partner health insurance coverage, and more) designed to help you live your best life, however you define it. And our best-in-class learning and development approaches, mentorship, and access to innovators across the world will help you grow your skills and reach your career goals. Because when you're at your best, nothing stands between you and your next breakthrough.