Quality Complaints & CAPA Investigator

BioPharma Consulting JAD Group; Juncos (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

Data analysis

Technical writing

Project management

Cross-functional teamwork

Microsoft Office

Bilingual EN/ES

Education

Bachelor's degree with related experience

Tools

Microsoft Office Suite (Excel, Outlook, Teams)

Job description

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.