Specialist Quality Complaints- 35796

Cis-International-LLC; Juncos (PR); On-site; USD 70,000 - 95,000; Full time

Job summary

Amgen seeks a skilled professional to support the product complaint system, lead investigations, and analyze data to detect signals, enabling timely corrective actions. The role emphasizes high-quality, science-based investigations and clear, concise documentation for non-technical reviewers.

The candidate should excel in writing, project management, and cross-functional collaboration within a GMP environment to ensure compliance and patient safety in a fast-paced setting.

Qualifications

• Doctorate or Master’s with 2+ years related experience.
• Bachelor’s degree with 4+ years related experience.
• Associate’s degree with 8+ years related experience.
• High school/GED with 10+ years related experience.

Responsibilities

• Maintain and update the complaints database as information becomes available and summarize closed investigations.
• Review and approve investigations to ensure they are concise, clear, and science-based.

Skills

Project management

Written & verbal comms

GMP CAPA knowledge

Teamwork in matrix

Problem solving

Leadership

Microsoft Office

Education

Doctorate/Master's + 2y exp

Bachelor + 4y exp

Associates + 8y exp

High school/GED + 10y exp

Tools

Microsoft Office (Excel/Outlook)

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