Specialist Quality Complaints

Biopharma-Consulting-Jad-Group; Juncos (PR); On-site; USD 70,000 - 90,000; Part time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Project management

Written and verbal communication

Team collaboration

Detail-oriented

Leadership in GMP

Analytical problem solving

Customer service

Decision making

Education

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

Tools

Microsoft Excel

Microsoft Outlook

Microsoft Teams

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 elevate 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