Product Complaint Analyst 2

Target PR Range: $36.25–$45.00/hr, depending on experience.

Responsibilities

• Reviews individual cases, assesses for potential adverse events for escalation to Regulatory in a timely manner.
• Reviews individual cases for the evaluation of complaints, including assessment, investigation, containment, and determination of escalation.
• Ensures adequacy of complaint records to GMP Standards (e.g., investigations, CAPA, NCs).
• Participates and conducts tasks associated with rotational monitor activities of Quality Assurance escalation mailbox.
• Facilitates the evaluation of complaints, including assessment, investigation, containment, review, approval, and determination of ongoing needs.
• Participates, facilitates, and/or supports complaint investigations and resulting CAPA activities.
• Completes other activities as assigned.

Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Requirements

• Bachelor’s Degree.
• 1–3 years recent experience in Quality/Regulatory Affairs in an in vitro diagnostics device or medical device company.