Specialist Quality Complaints

ECHO Consulting Group Inc; Juncos (PR); Presencial; USD 90.000 - 120.000; Jornada completa

Descripción de la vacante

ECHO Consulting Group Inc. is seeking an experienced Product Complaint Investigator to support Amgen’s product complaint system.

The role involves leading investigations, data analysis, and proactive trending to detect signals and initiate timely actions. The position requires strong writing skills to translate complex technical investigations into clear reports, effective collaboration across functions, and CAPA follow-through.

Formación

• Doctorate or Master’s degree required with related experience.
• Bachelor’s degree with 4+ years related experience accepted as alternative.
• Associates with 8+ years or high school with 10+ years of related experience.
• Experience in quality/compliance and CAPA preferred.

Responsabilidades

• Support product complaint investigations and database management.
• Lead and manage investigations and perform data analysis.
• Review and approve investigations to ensure science-based conclusions.
• Follow up on corrective actions and closure letters to patients/business partners.
• Communicate and escalate complaints as needed.
• Represent site on product complaint network.

Conocimientos

Project management

Cross-functional leadership

Verbal & written comms

Team collaboration

Leadership

Problem solving

Analytical skills

Customer service

Decision making

GMP compliance

Educación

Doctorate or Master’s with 2+ yrs related exp

Bachelor’s + 4 yrs related exp

Associates + 8 yrs related exp

High school/GED + 10 yrs related exp

Herramientas

Microsoft Office

Excel

Teams

Descripción del empleo

ECHO Consulting Group is a leader in providing solutions for the pharmaceutical, biotechnology, medical devices, and food industries. ECHO Consulting Group delivers high-quality solutions in CQV, quality management, regulatory compliance, manufacturing support, and project management. We are committed to offering exciting career opportunities in a workplace that values trust, respect, teamwork, creative talent, enthusiasm, and diligence. We are looking for talented professionals who are passionate about quality, collaboration, and delivering results. We believe great talent deserves great rewards. That’s why we offer a competitive compensation package and professional development.

Summary of Role:

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.

Responsibilities:

• 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.

Shift: Administrative

Location: Juncos, PR

Education: Doctorate OR Masters + 2 years of directly related experience OR Bachelors + 4 years of directly related experience OR Associates + 8 years of directly related experience OR 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 escalation, as necessary.

Equal Employment Opportunity

ECHO Consulting Group, Inc. is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or membership in any other class protected by federal, state, or local law.

We assure you that your opportunity for employment with ECHO Consulting Group, Inc. depends solely on your qualifications.