QA Complaints Specialist

Industry: Pharmaceutical / Biopharmaceutical

We are seeking an experienced QA Complaints Specialist with 5+ years of experience in pharmaceutical or biopharmaceutical quality environments. The ideal candidate will have strong hands‑on experience managing product quality complaints, conducting and reviewing complaint investigations, evaluating regulatory reportability, and supporting CAPA and quality system activities within a cGMP‑regulated environment.

The individual will work closely with Quality Assurance, Manufacturing, QC, Regulatory Affairs, Pharmacovigilance, Customer Service, and other cross‑functional teams to ensure complaints are thoroughly investigated, appropriately documented, and closed within established timelines.

• Manage product quality complaints throughout the complete complaint lifecycle, including intake, assessment, classification, investigation, evaluation, and closure.
• Review incoming complaints for completeness, accuracy, product information, and potential quality or patient‑safety impact.
• Conduct and/or coordinate investigations related to pharmaceutical product complaints.
• Review batch records, manufacturing records, laboratory data, stability information, distribution records, and other relevant quality documentation during investigations.
• Evaluate complaint information to determine potential regulatory reportability and escape reportable events to appropriate Quality, Regulatory Affairs, and Pharmacovigilance functions.
• Prepare clear, accurate, and technically sound complaint investigation reports and supporting documentation.
• Review investigation reports prepared by Manufacturing, QC, laboratories, Contract Manufacturing Organizations (CMOs), and other functional groups.
• Ensure complaint investigations are completed within established SOP, regulatory, and business timelines.
• Identify potential root causes and support investigations using appropriate root‑cause analysis methodologies such as 5 Whys, Fishbone/Ishikawa, and risk assessment tools
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• Identify recurring or systemic complaint issues and initiate or support CAPA activities when appropriate.
• Monitor complaint trends and prepare periodic metrics, dashboards, and reports to identify recurring product or process issues.
• Maintain accurate complaint records, databases, logs, and electronic quality system records.
• Ensure complaint documentation complies with GMP, GDP, data integrity, SOP, and internal quality‑system requirements
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• Partner with Manufacturing, QC, Engineering, Regulatory Affairs, Pharmacovigilance, Supply Chain, and Customer Service to obtain information required for investigations.
• Coordinate with external manufacturers, laboratories, vendors, distributors, healthcare professionals, and other stakeholders as required.
• Support product quality risk assessments and escalation of potentially significant quality issues.
• Participate in deviations, nonconformances, change controls, CAPA, and other quality‑system activities associated with complaint investigations.
• Support internal and external audits and regulatory inspections by providing complaint records and investigation documentation.
• Identify gaps in complaint processes and contribute to continuous improvement initiatives.
• Support development and revision of SOPs, work instructions, forms, and complaint‑management procedures.
• Ensure complaint records are inspection‑ready and appropriately maintained throughout the record‑retention period.

• Bachelor's degree in Pharmacy, Chemistry, Biology, Microbiology, Biotechnology, Life Sciences, Engineering, or related scientific discipline
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• 5+ years of experience in Quality Assurance, Product Complaints, Quality Systems, Manufacturing Quality, or a related function…