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Quality Complaints Specialist

Juncos, PR
QUALITY COMPLAINTS SPECIALIST
 
Description
 
Seeking a Specialist Quality Complaints to perform one or more of the following duties and responsibilities in support of product complaint system. Candidate must possess Regulatory Experience in the Pharmaceutical, Biotechnology or Medical Devices industry.

Responsibilities
  • Follow-up on corrective actions derived from investigations through completion. Depending on the nature and complexity of the complaint, the specialist may be responsible of conducting and documenting the investigation.
  • Supporting the product complaint system through; 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.
  • Ensure complaint related investigations are concise, clear and science-based by reviewing and approving such investigations.
Skills and Qualifications
  • Deviation investigations
  • Root cause analysis experience
  • Investigation experience (NC/CAPA)
  • Initiate and lead cross functional teams
  • Presentation skills
  • Good interpersonal skills and problem solving
  • Strong Project Management skills
  • Strong organizational skills
  • Fully bilingual: oral and written
  • Leadership and team-building
Requirements
 
Doctorate degree in sciences or Master's degree in sciences and 3 years of directly related experience (Specialist Quality Complaints) or Bachelor's degree in sciences and 5 years of directly related experience.

Integrated Technology and Compliance Services is an Equal Opportunity Employer

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