Specialist Quality Complaints

Location: Caguas, PR
Date Posted: 10-23-2017
SPECIALIST QUALITY COMPLAINTS
 
 
Description
Seeking a Specialist Quality Complaints that supporting the product system through; leading and managing product investigations, performing data analysis and trending information on time. Candidate must possess Regulatory Experience in the Pharmaceutical, Biotechnology or Medical Devices industry.
 
Responsibilities
  •  Ensure the complaint related investigations are concise, clear and science-based by reviewing and approving such 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.
  • Responsible of conducting and documenting the investigation (On occasion).
  • Follow-up on corrective actions derived from investigations through completion.
  •  Keep the complaints database updated as soon as factual information is available and summarize closed investigations into the database accurately.
 Skills and Qualifications
  • Good interpersonal skills and problem solving
  • Strong Project Management skills
  •  Strong organizational skills
  •  Experience leading cross-functional teams
  •  Fully bilingual: oral and written
  •  Presentation skills
  •  Ability to handle multiple projects simultaneously
  •  Leadership and team-building
 Requirements
  • Doctorate degree in sciences or Master's degree in sciences and 3 years of directly related experience or Bachelor's degree in sciences/engineering and 5 years of directly related experience.
 
Integrated Technology and Compliance Services is an Equal Opportunity Employer
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