Job Description
Job 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 inc...
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 inc...