Specialist Quality Complaints

CIS International LLC; Juncos (PR); On-site; USD 80,000 - 110,000; Full time

Job summary

CIS International LLC is seeking a professional to support the product complaint system by leading investigations, performing data analysis, and trending complaint information to proactively detect signals and take timely actions.

Responsibilities include updating the complaints database, reviewing investigations for clarity and science-based rationale, and following up on corrective actions through completion. Strong writing skills are essential.

Qualifications

• Doctorate or masters with related experience required.
• Bachelor's degree with related experience required.
• Associates degree with related experience required.
• High school/GED with related experience required.
• Experience in project management, RCA, CAPA preferred.

Responsibilities

• Maintain and update complaints database with factual information.
• Review and approve investigations to ensure concise, science-based content.
• Follow up on corrective actions through to completion.
• May conduct and document investigations depending on complexity.
• Communicate complaints and escalate as needed; generate closure letters.

Skills

Project management

Cross-functional leadership

Analytical skills

Written communication

Problem solving

Leadership

Team collaboration

Customer service

GMP compliance

Microsoft Office

Education

Doctorate or Masters + 2 years of directly related experience

Bachelor's + 4 years of directly related experience

Associates + 8 years of directly related experience

High school/GED + 10 years of directly related experience

Experience in project management, root cause analysis, CAPA determination

Quality mindset and deep compliance knowledge

Proficient in Microsoft Office Programs (Excel, Outlook) and Teams

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.

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 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.
• 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.