Complaints Specialist

QA Complaints InvestigatorRequired Skills & Experience Bachelor's degree in Engineering, Life Sciences, or a related field Minimum of 3 years of experience in a regulated industry (pharma, biotech, or medical device) Experience with complaint investigations and quality systems Knowledge of regulatory requirements (cGMP, 21 CFR Part 820, ISO 13485) Strong analytical, problem-solving, and organizational skills Excellent written and verbal communication skills Proficiency with Microsoft Office; experience with Veeva or other QMS systems preferred Basic understanding of statistics and data analysis Nice to Have Skills & Experience Experience supporting device or combination product manufacturing/packaging Familiarity with parenteral products and sterile operations Experience with deviation investigations, CAPA processes, and trending analysis Demonstrated ability to manage multiple investigations in a high-volume environmentJob Description The QA Complaints Investigator is responsible for supporting complaint handling and investigation activities for the Concord manufacturing site.Key responsibilities include: Conduct thorough complaint investigations related to manufacturing and packaging, including prefilled devices, drug-device combination products, and drug products. Initiate and support technical investigations, including trend workflows (TW), root cause investigations (RCIs), and associated tasks, as applicable. Perform routine and ad hoc trend analysis to evaluate product and process performance, including quarterly reviews. Meet established complaint team productivity and cycle time metrics. Partner cross functionally with SMEs across Quality, Manufacturing, Engineering, and Technical Services to support investigations. Maintain ownership and accountability for all assigned investigations and associated system tasks. Monitor, triage, and document incoming complaints on a daily basis. Compile and report complaint metrics, including monthly, quarterly, and ad hoc analysis. Develop a strong understanding of device, combination product, and parenteral packaging processes to effectively support investigations. Collaborate with internal and external stakeholders to provide timely updates and ensure high quality customer service. Support continuous improvement initiatives and productivity efforts within the complaints function. Prepare and present complaint data and insights to site leadership, flow teams, and process teams. Insight Global