Quality Complaints Specialist - Product Investigations

Support the product complaint system at a leading biotechnology company in Juncos, Puerto Rico. You will lead and manage product complaint investigations and use data analysis and trending to detect signals early and drive timely action.

What you'll do

• Keep the complaints database current and accurately summarize closed investigations.
• Review and approve complaint investigations to make sure they are concise, clear and science-based.
• Lead and document investigations directly when the nature or complexity of the complaint requires it.
• Follow up on corrective actions from investigations through completion.
• Trend complaint data to proactively detect signals and recommend actions.
• Communicate and escalate complaints, represent the site on the product complaint network, and issue closure letters to patients and business partners.

Requirements

• Bachelor's degree + 4 years (or Master's + 2, Associate's + 8, High School + 10, or a Doctorate) of directly related experience.
• GMP quality experience with complaint or quality investigations, root cause analysis and CAPA determination.
• Excellent technical writing: able to turn a highly technical investigation into a clear document for non-technical reviewers.
• Project management and experience leading cross-functional teams across multiple projects.
• Strong communication, facilitation and presentation skills; able to work independently in a matrix environment.
• Proficient in Microsoft Office (Excel, Outlook) and Teams. Bilingual English/Spanish preferred.