Specialist Quality Complaints- 35796

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

Job summary

Amgen is seeking a specialist to support the product complaint system by leading and managing investigations, analyzing data, and trending complaints to proactively detect signals and drive timely actions. The role requires strong writing, cross-functional collaboration, and the ability to translate technical findings into concise documents for non-technical reviewers.

The position is full-time and on-site at the Juncos, PR location, with potential overtime and weekend shifts.

Qualifications

• PhD or Master’s with relevant experience required.
• Bachelor’s with relevant experience also acceptable.
• Associates with extensive related experience acceptable.
• High school/GED with extensive related experience acceptable.

Responsibilities

• Lead and manage product complaint investigations.
• Perform data analysis and trend complaint information to detect signals.
• Keep complaints database updated and summarize investigations.
• Follow up on corrective actions through completion.
• Prepare clear, concise, and science-based investigations.

Skills

Project management

Written and verbal communication

Team collaboration

Leadership and problem solving

Customer service

Analytical thinking

GMP/compliance awareness

Computer literacy (MS Office)

Education

Doctorate or Master’s + related experience

Bachelor’s + related experience

Associates + related experience

High school/GED + related experience

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