Specialist Quality Complaints- 35796

CIS International LLC; Juncos (PR); On-site; USD 60,000 - 90,000; Full time

Job summary

Amgen seeks a dedicated specialist to manage the product complaint system, lead investigations, and analyze data to detect signals. You will ensure concise, science-based investigations and follow up on corrective actions, collaborating with cross-functional teams in a matrix GMP environment.

The role requires excellent writing skills to translate technical findings into clear documents for reviewers and stakeholders, with potential site representation on the complaint network and closure

Qualifications

• Doctorate or Masters + 2 years of directly related experience.
• Bachelors + 4 years of directly related experience.
• Associates + 8 years of directly related experience.
• High school/GED + 10 years of directly related experience.

Responsibilities

• Lead product complaint investigations and data analysis.
• Keep the complaints database updated and summarize investigations.
• Follow-up on corrective actions and closure of investigations.
• Communicate and escalate complaints and generate closure letters as needed.

Skills

Project management

Cross-functional leadership

Written communication

Verbal communication

GMP knowledge

Problem solving

Analytical thinking

Customer service

Microsoft Excel

Microsoft Outlook

Microsoft Teams

Education

Doctorate or Masters

Bachelors

Associates

High school/GED

Tools

Microsoft Excel

Microsoft Outlook

Microsoft Teams

Job description

SUMMARY

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.

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.
• 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.

EDUCATION

• Doctorate orMasters + 2 years of directly related experience.
• Bachelors + 4 years of directly related experience.
• Associates + 8 years of directly related experience.
• High school/GED + 10 years of directly related experience.

PREFERRED QUALIFICATIONS

• 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.

SKILLS

• Strong project management skills, experience leading cross-functional teams, and the ability to handle multiple projects simultaneously is a must.
• Excellent written and verbal communication skills, including facilitation and presentation skills.
• Able to work in a team-oriented, matrix environment and work effectively with diverse departmental groups.
• Be self-motivated, able to interface effectively with various levels, attentive to details and able to prioritize and meet deadlines, and must possess excellent leadership, problem solving, analytical, influencing and customer service skills to operate and deliver results in a matrix-managed GMP environment.
• Computer literacy, independently understand, follow and implement instructions, work independently or as a team player and collaborate with outside resources, and the ability to evaluate issues, make decisions and determine when to elevate, as necessary.

WORK METHODOLOGY

• Full on site job in Juncos, PR
• Full time job
• Expected project duration: 5 months for the first contractwith a high possibility of extension based on performance and budget.
• Administrative Shift(weekends and overtime may also be required).
• Available Positions: 2
• Expected hiring date: October 2026