Quality Complaints Specialist — CAPA & Analytics

BioPharma Consulting JAD Group; Juncos (PR); Hybrid; USD 65,000 - 90,000; Full time

Job summary

BioPharma Consulting JAD Group seeks a Specialist Quality Complaints to manage the product complaint system at a biopharmaceutical site in Juncos, PR. The role leads investigations, analyzes data, and trends complaints to detect signals and take timely actions.

Responsibilities include maintaining the complaints database, approving investigations, following CAPAs through completion, and translating technical findings for non-technical reviewers while working in a GMP, matrix environment.

Qualifications

• Education options include Doctorate or Master’s with direct related experience.
• Bachelor’s with related experience or higher acceptable.
• High school diploma with 10 years related experience acceptable.

Responsibilities

• Keep the complaints database current and summarize closed investigations.
• Review and approve investigations to ensure clarity and science-based content.
• Follow up on CAPAs from investigations through completion.
• Conduct and document investigations for complex cases.
• Translate technical investigations into concise documents for non-technical reviewers.
• Communicate and escalate complaints; represent the site on the product complaint network.

Skills

Project management

Cross-functional leadership

Technical writing

GMP compliance

Education

Doctorate or Master’s with experience

Bachelor’s with experience

Associate’s with experience

High school diploma with experience

Job description

BioPharma Consulting JAD Group seeks a Specialist Quality Complaints to manage the product complaint system at a biopharmaceutical site in Juncos, PR. The role leads investigations, analyzes data, and trends complaints to detect signals and take timely actions.

Responsibilities include maintaining the complaints database, approving investigations, following CAPAs through completion, and translating technical findings for non-technical reviewers while working in a GMP, matrix environment.