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

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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

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

We are searching for the best talent for an Investigator - Capabilities in Shepherdsville, KY.

The Investigator - Capabilities plays a pivotal role in ensuring the integrity of pharmaceutical distribution by leading non-conformance investigations. The Specialist is responsible for analyzing discrepancies in processes and practices, recommending actionable solutions, and collaborating with various teams to maintain compliance with industry standards. The successful candidate will champion a culture of continuous improvement by using data analysis and investigation findings to uphold the highest standards of quality and regulatory compliance.

Duties and Responsibilities:

• Follow up to resolve corrective actions adequately addressed root cause of an NC event
• Report and track deviations, events and key process parameters and provides reports to management on trending, and status as requested
• Identify and implement process improvements related to safety, environmental, quality, compliance, productivity, yield, and cost
• Implement process improvements within the change control system
• Recognize and act on potential compliance issues and opportunities for process changes/continuous improvement
• Multi-task and prioritize projects with challenging deadlines
• Partner with cross functional teams and warehouse leadership to implement process improvements
• Assure regulatory compliance and technical feasibility of proposed changes
• Serve as project manager for the change process and provide coordination to ensure timely and compliant implementation of process improvements
• Review, edit, and approve SOP and Work Instruction revisions

Qualifications:

Required:

• A minimum of an Associate’s Degree, Vocational, Certificate, Technical, and/or equivalent degree required.
• Minimum 2 years of working in a Supply Chain environment.
• Ability to read, analyze and interpret procedure manuals, common scientific and technical journals, basic financial reports and legal documents, general business periodicals and government regulations.
• Excellent written and oral communication skills.

Preferred:

• Experience as an Investigator focusing on investigating distribution center operations nonconformances within strict timelines.
• Proficiency as a Technical Writer, capable of producing audit-ready records that document the distribution center's resolution of nonconformances in accordance with quality practices.
• Background as a Project Manager, with the ability to collaborate effectively with distribution supervisors, document specialists, and quality engineers to address issues and enhance operations.
• Familiarity as a Technologist, with expertise in utilizing quality event and change control management systems, specifically COMET, document control systems like VeevaVault, and learning management systems such as SUMMIT.

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 and 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 email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.