Specialist Quality Complaints

Inteldot has over 10 years in the life science industry with allocations a cross Puerto Rico, United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico. 

Description: 

Supporting the product complaint system; leading and managing product complaint investigations, performing data analysis and trending of complaint information to proactively detect signals and take appropriate actions in a timely manner. 

 Responsibilities: 

• Keep the complaints database updated as soon as factual information is available and summarize closed investigations into the database accurately. 
• Ensure complaint related investigations are concise, clear and science-based by reviewing and approving such investigations. 
• Follow-up on corrective actions derived from investigations through completion. 
• Responsible of conducting and documenting investigations. 
• Communication and escalation of complaints, site representation on the product complaint network and generation and issuance of closure letters to patients and business partners.  

 Competencies / Skills: 

• Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device Manufacturing processes).
• Experience leading cross-functional teams, and the ability to handle multiple projects simultaneously.
• Familiarity with basic project management tools.

Education: 

 Master's degree and 3 years of Quality/Manufacturing experience OR Bachelor's degree (Science Field) and 5 years of Manufacturing experience. 

Compensation and Benefits:   

• Employment (W2) and Professional Services Contract (480) available. 
• Administrative, per project needs. Support during extended hours including weekends, as per business needs, in a flex commuter work setting with the flexibility to be onsite if it is needed. 
• Competitive Pay Rate 

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