Specialist Quality Complaints

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.

Requirements

• 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