Johnson & Johnson, Quality Analyst - Application via WayUp

Overview

Johnson & Johnson, Quality Analyst - Application via WayUp. This role is with Johnson & Johnson. WayUp is partnering with Johnson & Johnson to hire top talent.

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

Location : Shepherdsville, Kentucky, United States

Responsibilities

• Quality and compliance product receiving process, including receiving inspection activities such as review of temperature monitoring devices and systematic transactions in Warehouse Management System and / or SAP.
• Monitor and follow Quarantine / Hold / Stop-Ship / Recall processes and notices.
• Product refusals process activities, including 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.
• Adhere to Deviation, Corrective and Preventative Action (CAPA), and Change Controls processes and Quality Management Systems.
• Adhere to Records Management and Retention processes and Training processes.
• Support internal and external audits.
• Plan, support, and coordinate quality and compliance programs to ensure effective and consistent processes by performing 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 Standard Operating Procedures (SOPs), Work Instructions (WI), and other documents as needed.
• Drive innovation within functional areas while ensuring initiatives are delivered in a compliant and safe manner.
• Identify opportunities to continuously improve quality, cost, and time factors in alignment with Janssen Commercial Quality and DELIVER Supply Chain objectives.
• Identify business issues, communicate to management, prioritize actions, and lead improvement opportunities in collaboration with Supply Chain partners.
• Perform gap assessments in local procedures to Johnson & Johnson Global Standards, Business processes, and External Standards.
• Support New Product Launch activities at the Distribution Center, including Master Data setup.
• Ensure compliance with local, state, federal, and international regulations and standards.
• Evaluate overall compliance risk and recommend corrective actions, tracking progress.
• Make quality decisions balancing compliance risks with business needs.
• Provide compliance oversight for end-to-end clinical supply chain processes and for end-to-end Re-Pack-Re-Label processes.
• Monitor and review temperature data for the Distribution Center and ancillary areas.
• Support 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.

Qualifications / Requirements

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. 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.

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