Inteldot has over 14 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:

Primary responsibilities include: 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.
  • On occasion, depending on the nature and complexity of the complaint, the specialist may be responsible of conducting and documenting the investigation.
  • Therefore, the candidate must possess excellent writing skills that include closing the gap between a highly technical investigation into a simple and concise document that can be understood by non-technical reviewers.
  • May also include: 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:

  • Experience in manufacturing/packaging deviations, Root Cause Analysis, complaint investigations, project management and compliance.

Education:

  • Master's degree and 3 years of directly related experience to the job or bachelor's degree and 5 years

Compensation and Benefits:

  • Employment (W2) and Professional Services Contract (480) available.
  • As per business needs.
  • Competitive Pay Rate