Specialist Quality Complaints

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

We are seeking a Specialist Quality Complaints to support the product complaint system at a biopharmaceutical manufacturing site in Juncos, Puerto Rico. This role leads and manages product complaint investigations and performs data analysis and trending of complaint information to proactively detect signals and take timely, appropriate action.

Key Responsibilities

• Keep the complaints database current as factual information becomes available, and accurately summarize closed investigations.
• Review and approve complaint investigations to ensure they are concise, clear and science-based.
• Follow up on corrective and preventive actions (CAPAs) resulting from investigations through completion.
• Depending on complaint complexity, conduct and document investigations directly.
• Translate highly technical investigations into simple, concise documents understandable by non-technical reviewers.
• Communicate and Escalate complaints, represent the site on the product complaint network, and prepare and issue closure letters.

Education (one of the following)

• Doctorate degree; OR
• Master's degree + 2 years of directly related experience; OR
• Bachelor's degree + 4 years of directly related experience; OR
• Associate's degree + 8 years of directly related experience; OR
• High school diploma/GED + 10 years of directly related experience

Preferred Qualifications

• Experience in project management, root cause analysis and CAPA determination
• Quality mindset and deep knowledge of GMP compliance
• Proficiency in Microsoft Office (Excel, Outlook) and Microsoft Teams

Key Skills

• Strong project management skills; experience leading cross-functional teams and handling multiple projects simultaneously (a must)
• Excellent written and verbal communication, including facilitation and presentation skills; excellent technical writing
• Able to work in a team-oriented, matrix environment with diverse departmental groups
• Self-motivated, detail-oriented, able to prioritize and meet deadlines
• Leadership, problem-solving, analytical, influencing and customer service skills in a GMP environment
• Ability to evaluate issues, make decisions and determine when to escape

• Contract position: approximately 5.5 months (October 2026 - March 2027), with possible extension
• Shift: Administrative shift
• Days: Monday to Friday, 8 hours/day (40 hours/week)
• On-site in Juncos, Puerto Rico