About this role
Inteldot has over 15 years in the life sciences industry, with operations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
Administrative Shift
Job Description:
Primary responsibilities include supporting the product complaint system at Amgen 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.
Requirements:
- Experience in project management, root cause analysis, CAPA determination.
- Quality mindset and deep compliance knowledge.
- Proficient in Microsoft Office Programs (Excel, Outlook) and usage of Teams.
Functions:
- 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 the investigation.
- 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.
- Communication and escalation of complaints, site representation on the product complaint network and generation and issuance of closure letters to patients and business partners.
Education
- Doctorate OR Masters + 2 years of directly related experience OR Bachelors + 4 years of directly related experience OR Associates + 8 years of directly related experience OR High school/GED + 10 years of directly related experience