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

Job description

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 SUMMARYThe 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. KEY RESPONSIBILITIES 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, continuous improvement, transparency, timely escalation, inspection readiness, and a strong quality culture at the site. Perform other responsibilities as assigned by the supervisor in support of site quality objectives, business priorities, and compliant complaint handling operations. KEY INTERFACES Global complaint team, assigned investigation contributors, and cross-functional stakeholders (e.g., Manufacturing, QC, Engineering, Supply Chain, Packaging, MSAT). Other sites and affiliates (as applicable) to align investigation strategy, evidence, and outcome for site-manufactured product complaints. Quality leadership for escalation, risk communication, and alignment on investigation approach or follow-up actions. External manufacturers/partners and laboratories (as applicable) to obtain and evaluate investigation input and analytical results. REQUIRED KNOWLEDGE & SKILLSKnowledge of complaint handling, site-based investigations, field sample assessment, quality event management, cGMP, Good Documentation Practices, and applicable regulatory expectations in a regulated environment. Ability to collect, assess, and interpret objective evidence, including field samples, batch records, manufacturing and laboratory data, distribution information, procedures, and other relevant records. Ability to conduct structured investigations, assess potential root cause, recurrence, trend, and product or patient risk, and confirm that conclusions are supported by objective evidence. Ability to identify the need for additional investigation, escalation, NC or CAPA linkage, and follow-up actions in accordance with global and site procedures. Strong written communication, analytical, and documentation skills to prepare clear investigation narratives, evidence summaries, rationales, conclusions, and closure information. Ability to work independently and collaboratively, coordinate cross-functional inputs, manage multiple complaint records, meet deadlines, and drive timely closure. EDUCATION & EXPERIENCE REQUIREMENTS Bachelor’s degree in Life Science or related discipline (or equivalent experience) is required. Minimum of 2-4 years of experience performing, documenting, or supporting quality investigations (complaints, deviations, nonconformances, or similar quality events). Experience working within quality systems and with applicable regulatory and compliance requirements. Demonstrated ability to prepare clear, concise, complete, and actionable investigation documentation. Proven critical thinking, problem-solving, and decision-making skills. Strong organization, prioritization, and time management skills. CORE COMPETENCIES Collaboration and teamwork. Strong commitment to Credo values. Customer focus. Comply with EHS rules and procedures at all times. Report all incidents, accidents, and near miss events. #LI-Onsite ======================================================== 社内公募ガイドライン 応募の際はAskGS内の社内公募ガイドラインをご一読いただき、応募ください。１８か月未満の方は応募前に上長及び担当BUHRの許可を取ってから応募ください。複数同時応募不可になります。 在籍期間に関わらず、書類選考を通して１次面接に進んだ場合は、社内公募に応募し選考に進むことを上司に報告してください。 社内紹介を行う場合は、Career Hub上の“社内紹介制度の概要”の詳細を理解した上で、コンプライアンスを守って紹介したものとみなします。 Required Skills: Preferred Skills: