Specialist Quality Complaints

ECHO Consulting Group•Juncos, PR

20h

About The Position

The Specialist Quality Complaints supports Amgen’s product complaint system by leading and managing product complaint investigations and analyzing and trending complaint information to identify potential signals and enable timely action. The specialist maintains accurate complaint database records, reviews and approves investigations to ensure they are concise, clear, and science-based, and follows corrective actions through completion. Depending on the nature and complexity of a complaint, the specialist may conduct and document the investigation. This requires the ability to translate technical investigations into concise, understandable documents for non-technical reviewers. The role may also involve communicating and escalating complaints, representing the site on the product complaint network, and preparing and issuing closure letters to patients and business partners. The position is based in Juncos, Puerto Rico, and has an administrative shift.

Requirements

Doctorate; or a master's degree and 2 years of directly related experience; or a bachelor's degree and 4 years of directly related experience; or an associate degree and 8 years of directly related experience; or high school diploma/GED and 10 years of directly related experience.
Strong project management skills and experience leading cross-functional teams.
Ability to handle multiple projects simultaneously.
Excellent written and verbal communication skills, including facilitation and presentation skills.
Ability to work in a team-oriented, matrix environment and effectively with diverse departmental groups.
Self-motivated, detail-oriented, and able to interface effectively with various levels, prioritize, and meet deadlines.
Leadership, problem-solving, analytical, influencing, and customer service skills to deliver results in a matrix-managed GMP environment.
Computer literacy and ability to independently understand, follow, and implement instructions.
Ability to work independently or as a team player and collaborate with outside resources.
Ability to evaluate issues, make decisions, and determine when escalation is necessary.

Nice To Haves

Experience in project management, root cause analysis, and CAPA determination.
Quality mindset and deep compliance knowledge.
Proficiency with Microsoft Office programs, including Excel and Outlook, and use of Teams.

Responsibilities

Lead and manage product complaint investigations.
Perform data analysis and trend complaint information to proactively detect signals and support timely action.
Keep the complaints database updated as factual information becomes available and accurately summarize closed investigations.
Review and approve complaint-related investigations to ensure they are concise, clear, and science-based.
Follow up on corrective actions resulting from investigations through completion.
As needed, conduct and document investigations based on the nature and complexity of a complaint.
Translate technical investigation findings into concise documents understandable to non-technical reviewers.
Communicate and escalate complaints as appropriate.
Represent the site on the product complaint network.
Generate and issue closure letters to patients and business partners.