Specialist Quality Complaints

SUMMARY

The Product Complaints and Surveillance Team is the function that performs and supports commercial and clinical GMP operations for product complaints of Amgen commercial and clinical distributed products. The Complaint Record Owner leads investigations and manages individual complaint records. Reviews, evaluates and investigates product complaints, as per applicable procedures.

The Quality Complaints role is accountable of owning and managing customer complaint investigations. Responsible of establishing the appropriate investigation scope and investigational plans based on procedural requirements, data obtained from each individual complaint record, from post-market signals, related deviations, supplier inputs, and reserve sample examinations or other testing where applicable. Accountable of appropriately conducting complex complaint investigations, settle corrective actions with their effectiveness and determine the steps necessary to ensure the accurate level of control for product in distribution.

SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

• Ensures quality of complaint records
• Applies analytical skills to evaluate complex situations using multiple sources of information
• Execution of regulatory and SOP requirements
• Anticipates and prevents potential issues with regulators
• Provides mentorship and technical advice
• Evaluates subject matter expert assessments
• Brings up potential Quality issues to Management

AUTHORITY

• Owns complex quality record content
• Determines situations which require escalation to management
• Determines when a complaint dictates further investigation
• Works under minimal direction
• Proposes revisions to SOPs in area of responsibility

BASIC EDUCATION/LICENSES

Doctorate degree

OR

Master's degree & 2 years of experience in quality and/or manufacturing experience in biotech or pharmaceutical industry

OR

Bachelor's degree & 5 years of experience in quality and/or manufacturing experience in biotech or pharmaceutical industry

PREFERRED QUALIFICATIONS

• Educational background in Life Science or Engineering
• Experience conducting investigations and root cause analysis
• Experience in customer complaint investigations
• Ability to lead all aspects of multiple projects simultaneously
• Outstanding attention to detail and organization skills, effective decision making skills, focus on process improvements, and ability to manage a large number of complex projects simultaneously.
• Ability to successfully handle workload to timelines
• Familiarity with basic project management tools
• Ability to interact in cross-functional teams and negotiate a position after taking feedback from multiple sources
• Demonstrated ability to consistently deliver timely, and high-quality results
• Ability to operate in a matrix or team environment
• Understanding of the applicable manufacturing/testing processes (i.e., API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
• Proficient in written and verbal communication skills in English and Spanish.
• Good communication and presentation skills
• Ability to travel +/- 10% of time to domestic and international Amgen sites

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and demonstrates its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.