Description

ICompany Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

Work in AbbVie's global quality organization processing complaints and inquiries about pharmaceutical products, medical devices/vigilance, and combination products. This position requires serving as an expert and consultant to the team of analysts, as well as providing direct support to the supervisor in tasks of control and team monitoring. Additionally, the position requires constant interaction with AbbVie's internal and external clients such as physicians, nurses, pharmacists, hospital staff, risk managers, purchasing agents, sales representatives, the general public, manufacturing centers, technical support, and the commercial organization in relation to AbbVie product complaints.

MAJOR RESPONSIBILITIES

• Ensure that complaint records comply with global requirements.
• Provide support in managing key performance and management indicators for the work area.
• Ensure proper documentation, investigation, and review of all complaints involving a reported event not related to medical quality.
• Support root cause analysis processes and assist in the development and implementation of corrective and preventive action plans required in the department.
• Provide quality customer service by coordinating returned samples for investigation, follow-up activities such as product replacement, and complaint categorization.
• Review complaint records to ensure they comply with GMP standards and can be used for reporting and/or regulatory documents.
• Ensure that complaint documentation complies with good documentation practices, GMP (Good Manufacturing Practice), and GCP (Good Clinical Practice). Additionally, ensure complaint files meet all regulatory requirements.
• Accurately capture reportable events and notify functional groups as applicable.
• Ensure compliance with corporate and legal EHS (Environment, Health, and Safety) requirements by adhering to internal policies and procedures. Also, ensure compliance through strategies, internal controls, communications, and necessary training.
• Comply with all company policies and guidelines.
• Perform all other functions inherent to the position and those assigned by the immediate supervisor.

Qualifications

EDUCATION

• Bachelor's degree in technological fields, engineering, or a scientific focus (Certified Medical Laboratory Technician or certified nurse), or 3+ years of relevant work experience.
• B2+ English proficiency required.

EXPERIENCE

• More than 2 years of experience in the medical industry (regulated companies with good manufacturing practices) or in clinical laboratories.
• Knowledge of complaint management systems.

SKILLS

• Critical thinking
• Collaboration with cross-functional teams and stakeholders
• Analytical thinking and technical writing
• Continuous improvement mindset
• Customer orientation and quality service
• Process execution and problem resolution
• Regulatory compliance and documentation
• Exemplifies AbbVie Ways of Working

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.htmlI