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Job Function: Quality
Job Sub Function: Quality Assurance
Job Category: Professional
All Job Posting Locations: Shizuoka, Japan
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.
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 & Skills
•Knowledge 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.
