[Innovative Medicine] Complaint Handling Quality Staff, OQ Group (Fuji Plant)

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 jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Quality Job Sub Function: Quality Assurance Job Category: Professional All Job Posting Locations: Shizuoka, Japan 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 POSITION SUMMARY The Complaint Handling Quality Staff is accountable for complaint handling activities as complaint handling staff/investigator, including confirming and assessing field samples, executing the investigation, documenting investigation activities and conclusions in the complaint record, and driving the record through closure in accordance with applicable procedures and regulations. The role ensures that relevant information and evidence are collected, investigation activities are appropriately coordinated with required stakeholders, risk and potential root cause are assessed based on objective evidence, and the final investigation outcome is clearly documented to support timely and compliant complaint closure. SCOPE This is a site-based role applicable to complaint handling staff / investigators responsible for site-owned complaint records, including complaints received from other company affiliates for products manufactured at the site. The scope includes confirming and assessing field samples and related complaint information, executing and documenting site-based investigation activities, coordinating required inputs from applicable functions, sites, affiliates, laboratories, and external partners, and driving the complaint record through timely and compliant closure. The role supports alignment on investigation approach, evidence, rationale, conclusion, and follow-up actions across functions and sites as applicable, while ensuring that the investigation record remains complete, accurate, and inspection ready.

Complaint Handling Staff / Investigator Execute site-based complaint investigations in accordance with applicable procedures and regulatory requirements, including field sample confirmation, objective evidence assessment, and coordination with required functions, affiliates, sourcing sites, laboratories, and business partners. Document investigation activities in the complaint record, including assessment of batch, manufacturing, laboratory, distribution, field sample, and other relevant information, as applicable. Evaluate potential root cause, recurrence, trend, and risk; identify the need for escalation or additional investigation; and ensure follow-up actions, including NC or CAPA linkage when applicable, are defined, assigned, and tracked. Prepare clear, complete, and accurate complaint documentation, including the investigation narrative, evidence summary, rationale, conclusion, and closure information, while driving timely complaint closure. Support process monitoring, trending,