Quality Complaints Investigator & CAPA Lead

Biopharma-Consulting-Jad-Group; Juncos (PR); In loco; USD 70.000 - 90.000; Part-time

Descrizione del lavoro

Biopharma-Consulting-Jad-Group is seeking a Specialist Quality Complaints to support the product complaint system at a biopharmaceutical site in Juncos, Puerto Rico. This role leads investigations and performs data analysis to detect signals and trigger timely action.

You will maintain the complaints database, review investigations for conciseness and scientific accuracy, and contribute to cross-functional CAPA activities.

Competenze

• Bachelor’s/Master’s/Doctorate plus related experience in GMP/compliance.
• Experience with CAPA, investigations, and root cause analysis preferred.
• Strong written and verbal communication; ability to present findings clearly.

Mansioni

• Keep the complaints database current with new information.
• Review and approve investigations to ensure concise, science-based documentation.
• Follow up on CAPAs and ensure closure.
• Conduct investigations for complex cases when needed.
• Translate technical investigations for non-technical reviewers.
• Communicate and elevate complaints, prepare closure letters.

Conoscenze

Project management

Written and verbal communication

Team collaboration

Detail-oriented

Leadership in GMP

Analytical problem solving

Customer service

Decision making

Formazione

Doctorate degree

Master's degree + 2 years of related experience

Bachelor's degree + 4 years of related experience

Associate's degree + 8 years of related experience

High school diploma/GED + 10 years of related experience

Strumenti

Microsoft Excel

Microsoft Outlook

Microsoft Teams

Descrizione del lavoro

Biopharma-Consulting-Jad-Group is seeking a Specialist Quality Complaints to support the product complaint system at a biopharmaceutical site in Juncos, Puerto Rico. This role leads investigations and performs data analysis to detect signals and trigger timely action.

You will maintain the complaints database, review investigations for conciseness and scientific accuracy, and contribute to cross-functional CAPA activities.