Quality Complaints Specialist - Product Investigations

BioPharma Consulting JAD Group; Juncos (PR); Sur place; USD 70 000 - 100 000; Plein temps

Résumé du poste

BioPharma Consulting JAD Group in Juncos, Puerto Rico, is seeking a qualified professional to support the product complaint system. You will lead investigations, summarize findings, and ensure scientifically sound communications for non-technical reviewers.

The role requires GMP quality experience with complaints, strong technical writing, project management, and cross-functional collaboration. Bilingual English/Spanish is preferred.

Qualifications

• GMP quality experience with complaint investigations and CAPA.
• Excellent technical writing to translate investigations for non-technical reviewers.
• Experience leading cross-functional teams across multiple projects.
• Strong communication, facilitation and presentation skills.
• Bilingual English/Spanish preferred.

Responsabilités

• Keep the complaints database current and accurately summarize closed investigations.
• Review and approve complaint investigations to ensure conciseness and science-based conclusions.
• Lead and document investigations when required by the nature or complexity of the complaint.
• Follow up on corrective actions from investigations through completion.
• Trend complaint data to proactively detect signals and recommend actions.
• Communicate and elevate complaints, represent the site on the product complaint network, and issue closure letters to patients and business partners.

Connaissances

Data analysis

Technical writing

Project management

Cross-functional teamwork

Microsoft Office

Bilingual EN/ES

Formation

Bachelor's degree with related experience

Outils

Microsoft Office Suite (Excel, Outlook, Teams)

Description du poste

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 elevate complaints, represent the site on the product complaint network, and issue closure letters to patients and business partners.

• 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.

• Contract: 5 months, with possible extension
• Shift: Administrative, Monday–Friday (40 hours/week)
• Start: Immediate