Quality Complaints Specialist - Product Investigations

Biopharma-Consulting-Jad-Group; Juncos (PR); On-site; USD 78,000 - 100,000; Part time

Job summary

Biopharma-Consulting-Jad-Group in Juncos, Puerto Rico is seeking support for the product complaint system. You will lead and manage investigations, summarize findings, and drive timely corrective actions.

You will trend data, communicate with cross-functional teams, and issue closure letters to patients and business partners. A Bachelor's degree plus GMP experience is required; bilingual English/Spanish is preferred.

Qualifications

• Bachelor's degree + 4 years (or Master's + 2, Associate's + 8, High School + 10, or a Doctorate) of directly related experience.
• GMP quality experience with complaint or quality investigations, root cause analysis and CAPA determination.
• Excellent technical writing: able to turn a highly technical investigation into a clear document for non-technical reviewers.
• Project management and experience leading cross-functional teams across multiple projects.
• Strong communication, facilitation and presentation skills; able to work independently in a matrix environment.
• Proficient in Microsoft Office (Excel, Outlook) and Teams. Bilingual English/Spanish preferred.

Responsibilities

• Keep the complaints database current and accurately summarize closed investigations.
• Review and approve complaint investigations to make sure they are concise, clear and science-based.
• Lead and document investigations directly when the nature or complexity of the complaint requires it.
• Follow up on corrective actions from investigations through completion.
• Trend complaint data to proactively detect signals and recommend actions.
• Communicate and elevate complaints, represent the site on the product complaint network, and issue closure letters to patients and business partners.

Skills

GMP quality experience

Root cause analysis

CAPA determination

Technical writing

Project management

Cross-functional leadership

Communication

Education

Bachelor's degree in related field

Tools

Microsoft Excel

Microsoft Outlook

Microsoft Teams

Job description

Support the product complaint system at a leading biotechnology company in Juncos, Puerto Rico. You will lead and manage product complaint investigations and use data analysis and trending to detect signals early and drive timely action.

What you'll do

• Keep the complaints database current and accurately summarize closed investigations.
• Review and approve complaint investigations to make sure they are concise, clear and science-based.
• Lead and document investigations directly when the nature or complexity of the complaint requires it.
• Follow up on corrective actions from investigations through completion.
• Trend complaint data to proactively detect signals and recommend actions.
• Communicate and elevate complaints, represent the site on the product complaint network, and issue closure letters to patients and business partners.

• Bachelor's degree + 4 years (or Master's + 2, Associate's + 8, High School + 10, or a Doctorate) of directly related experience.
• GMP quality experience with complaint or quality investigations, root cause analysis and CAPA determination.
• Excellent technical writing: able to turn a highly technical investigation into a clear document for non-technical reviewers.
• Project management and experience leading cross-functional teams across multiple projects.
• Strong communication, facilitation and presentation skills; able to work independently in a matrix environment.
• Proficient in Microsoft Office (Excel, Outlook) and Teams. Bilingual English/Spanish preferred.

• Contract: 5 months, with possible extension
• Shift: Administrative, Monday–Friday (40 hours/week)
• Start: Immediate