· Receive, log, and track product complaints in compliance with customer quality agreements, internal procedures, and regulatory requirements.

· Assist in evaluating complaints for potential quality, safety, or regulatory impact.

· Support investigations into product complaints by gathering data, reviewing batch records, and coordinating with Manufacturing, Quality Control, and other departments.

· Document complaint investigations in accordance with GDP and ALCOA+ principles, ensuring accuracy and completeness.

· Escalate critical or serious complaints to QA management as appropriate.

· Support trending and analysis of complaint data; assist in identifying potential issues and recommending improvements.

· Participate in preparation for regulatory inspections, customer audits, and internal audits related to complaint management.

· Assist in revising or drafting SOPs, work instructions, and QA procedures related to complaint handling.

· Collaborate with QA and cross-functional colleagues to ensure timely closure of complaint investigations.

· Initiate SCARs, when deemed necessary, for non-conforming materials discovered in the manufacturing process.

· Coordinate cross-functionally with Procurement, Operations, and Quality teams to drive closure of SCARs and ensure supplier accountability.

· Maintain product retention samples in clean and organized Retain Room(s) that are compliant with all internal procedures and regulatory requirements.

· Discard product retention samples, as needed, with appropriate documentation following all regulatory requirements.

· Maintain audit readiness and compliance with FDA, EMA, ICH, and other regulatory expectations.

· All other activities commensurate with the role, as required

• Bachelor’s degree in a relevant scientific discipline (e.g., Chemistry, Biology, Microbiology, Pharmaceutical Sciences) or equivalent combination of education and experience
• Minimum of 2–4 years of experience in Quality Assurance within a GMP-regulated environment (pharmaceutical preferred)
• Demonstrated experience handling product complaints, investigations, or deviations
• Working knowledge of 21 CFR Parts 210 and 211 and applicable FDA guidance
• Proficiency in quality systems (e.g., TrackWise, MasterControl, or equivalent electronic QMS)
• Strong technical writing and documentation skills

• Thorough understanding of Good Manufacturing Practices (GMP) and data integrity principles (ALCOA+)
• Ability to conduct root cause analysis (e.g., 5 Whys, Fishbone, CAPA methodologies)
• Strong attention to detail with the ability to identify trends and systemic issues
• Effective cross-functional communication (Operations, QC, Regulatory Affairs, Customer Service)
• Ability to manage multiple investigations simultaneously while meeting regulatory timelines
• Critical thinking and decision-making in a regulated environment

• Ensure all complaint handling activities comply with 21 CFR Part 211, specifically Subpart J – Records and Reports (Complaint Files)
• Maintain complaint files in accordance with FDA data integrity expectations and internal SOPs
• Support FDA inspections, audits, and regulatory inquiries related to complaint handling
• Ensure timely reporting of adverse events, product quality complaints, and potential reportable events (e.g., Field Alerts, if applicable)