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:

Shepherdsville, Kentucky, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for a Quality Analyst to be located in Shepherdsville, Kentucky.

The Quality Analyst is responsible for the oversight and execution of Quality Management Systems and compliance at the Distribution Center. The Quality Analyst serves as a single point of contact to the Sr. Manager, Janssen Commercial Quality and Supply Chain partners on compliance related matters and is the liaison with multiple Quality and Compliance organizations to drive timely resolution of quality and compliance related issues. The Quality Analyst identifies business issues, identifies opportunities to continuously improve quality and compliance and leads improvement opportunities and problem solutions. The Quality Analyst implements and executes quality and compliance programs to ensure effective and consistent processes with established standards.

You will be responsible for:

• Quality and compliance product receiving process, including, but not limited to receiving inspection activities such as review of temperature monitoring devices and systematic transactions in Warehouse Management System and/or SAP

• Monitoring and following Quarantine/Hold/Stop-Ship/Recall processes and notices

• Product refusals process activities, including, but not limited to inspection and disposition

• Serve as single point of contact to internal and external partners on Distribution Quality related matters and liaise with multiple Quality organizations to drive timely resolution of Quality related issues

• Responsible for adherence to the Deviation, Corrective and Preventative Action (CAPA), and Change Controls processes and Quality Management Systems

• Responsible for adherence to the Records Management and Retention processes

• Responsible for adhering to the Training process

• Supporting internal and external audits

• Plans, support, and coordinates quality and compliance programs designed to ensure effective and consistent processes with established standards by performing the duties personally

• Provide quality and compliance oversight for execution of Protocols

• Notify/escalate critical quality issues to management in a timely manner

• Provide data/information/metrics to management for Quality System Management Reviews

• Develop and review of Standard Operating Procedures (SOPs), Work Instructions (WI) and other documents, as needed

• Drives innovation within functional areas while ensuring functional initiatives are delivered in a compliant and safe manner

• Identifies opportunities to continuously improve quality, cost and time factors, consistent with both Janssen Commercial Quality and DELIVER Supply Chain business objectives

• Identify business issues, communicates to management, prioritizes for action, and leads improvement opportunities and problem solutions in collaboration with other Supply Chain partners.

• Perform gap assessments in local procedures to Johnson and Johnson Global Standards, Business processes, and External Standards

• Support of New Product Launch activities at the Distribution Center, including, but not limited to Master Data (sIDMa) set-up

• Ensures compliance and remaining current with local, state, federal, and international regulations and standards

• Evaluate the overall compliance risk and recommending corrective actions and tracking progress

• Responsible for making quality decisions based upon assessments of compliance risks balanced with the overall business needs

• Compliance oversight for the end-to-end clinical supply chain processes, including, but not limited to re-stickering and other labeling activities

• Compliance oversight for the end-to-end Re-Pack-Re-Label processes, including, but not limited to Batch Record/Protocol activities

• Monitor and review temperature data for the Distribution Center and ancillary areas

• Supports 24/7 operations of the Distribution Center

• Operate in a team-based environment with minimum supervision

• Provide training to new hires (FTEs) and/or Contractors

• Interface collaboratively with other business partners and stakeholders

Qualifications / Requirements:

• A minimum of bachelor’s degree in an Engineering, Life Science, and Technical scientific or related discipline is preferred. In absence of a bachelor’s degree, special consideration would be considered for individuals who have related and background experience.

• A minimum of 2 years of experience in a highly regulated industry is required.

• Quality and Compliance experience in the Medical Device, Pharmaceutical or Consumer products industry and experience in distribution is preferred.

• Strong communication, teamwork, problem solving, decision-making, and root cause analysis skills are required.

• Experience with Warehouse Management Systems and SAP is preferred.

• Experience with Quality Management Systems such as COMET is preferred.

• Proficiency in organizational and project management skills is preferred.

• Experience with Temperature Control is preferred.

• This position may require up to a 10% of domestic travel.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

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.