Specialist Quality Complaints

At Amgen, our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With a focus on four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease—we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines.

About the role

Amgen is seeking a Specialist Quality Complaints as a Standard/Advanced Complaint Owner and member of the Product Complaints and Surveillance team. This team owns and carries out the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. The focus is on assuring complaint processes and systems remain fully compliant through quality operating standards and procedures to current and emerging internal and external requirements. The Specialist facilitates cross-functional teams to conduct complex complaint investigations, determines corrective actions and their effectiveness, and ensures the proper level of control for product in distribution. The role also involves aligning complaint closure requirements with pre-determined process step metrics to ensure timely closure of records.

Responsibilities

• Ensures quality of complaint records
• Facilitates cross-functional meetings to plan and coordinate the closure of records
• Applies analytical skills and product knowledge to evaluate complex situations using multiple sources of information
• Completes prioritized work plans
• Quickly advances issues that could impede the ability to close records according to action plans
• Maintains compliance with local and global processes
• Executes regulatory and SOP requirements
• Anticipates and prevents potential issues with regulators
• Provides guidance and technical advice
• Evaluates subject matter specialist assessments
• Raises potential Quality issues to Management

Qualifications

Basic Qualifications

• Doctorate degree
• OR Master’s degree and 2 years of quality experience
• OR Bachelor’s degree and 4 years of quality experience
• OR Associate’s degree and 8 years of quality experience
• OR High school diploma / GED and 10 years of quality experience

Preferred Qualifications

• 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry
• Bachelor’s Degree in a Science Field
• Ability to oversee multiple projects simultaneously
• Ability to successfully manage workload to timelines
• Familiarity with basic project management tools
• Ability to negotiate a position after taking feedback from multiple sources
• Demonstrated ability to consistently deliver on-time, high-quality results
• Ability to operate in a matrixed or team environment
• Understanding of applicable manufacturing/testing processes (i.e., API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
• Ability to travel +/- 10% of time to domestic and international Amgen sites

Benefits

From our competitive benefits to our collaborative culture, we support your professional and personal growth and well-being. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted, with actual salary varying based on relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible

Amgen fosters an inclusive environment of diverse, ethical, committed, and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients.