Quality Complaints Specialist - Product Investigations

BioPharma Consulting JAD Group

10d • Onsite

About The Position

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

Requirements

• Bachelor's degree and 4 years of directly related experience, or a Master's degree and 2 years, an Associate's degree and 8 years, a high school diploma and 10 years, or a doctorate.
• GMP quality experience with complaint or quality investigations, root cause analysis, and CAPA determination.
• Excellent technical writing skills, including the ability to turn a highly technical investigation into a clear document for non-technical reviewers.
• Project management experience and experience leading cross-functional teams across multiple projects.
• Strong communication, facilitation, and presentation skills.
• Ability to work independently in a matrix environment.
• Proficiency in Microsoft Office, including Excel and Outlook, and Teams.

Nice To Haves

• Bilingual English/Spanish.

Responsibilities

• Keep the complaints database current and accurately summarize closed investigations.
• Review and approve complaint investigations to ensure they are concise, clear, and science-based.
• Lead and document investigations directly when the nature or complexity of a 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.

What This Job Offers

• Career Level: Mid Level