Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Specialist Quality Complaints

Live

What you will do

Let’s do this, Let’s change the world! In this vital role you will own and executes the end-to end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement. The Specialist conducts facilitates cross-functional teams to conduct sophisticated complaint investigations, determines corrective actions with their efficiency and determines the steps vital to ensure the accurate level of control for product in distribution. Aligns' complaint closure requirements in adherence with pre-determined process step metrics to ensure timely closure of records. Their are two openings for this positions.

Specific responsibilities include but are not limited to:

• Facilitate cross-functional meetings to plan and coordinate the plan for 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
• Execution of regulatory and SOP requirements
• Anticipates and prevents potential issues with regulators
• Provides mentorship and technical advice
• Evaluates subject matter specialist assessments
• Raises potential Quality issues to Management

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients! The Specialist Quality Complaints professional we seek is an individual contributor with these qualifications.

Doctorate degree

OR

Master’s degree and 3 years of [Job Code’s Discipline and/or Sub-Discipline] experience

Or

Bachelor’s degree and 5 years of quality experience in a GMP regulated industry

Or

Associate’s degree and 10 years of quality experience in a GMP regulated industry

Or

High school diploma / GED and 12 years of quality experience in a GMP regulated industry

Beyond that, additional preferred qualifications are:

• 4+ years of quality and manufacturing and or Product Development/Safety/Research experience in biotech or pharmaceutical industry
• Demonstrated skill in facilitating complex investigations from initiation to completion
• Knowledge of Root Cause Analysis (RCA) process
• Expertise in development management and complex investigations
• Combination products expertise
• Demonstrated ability to deep dive into technical issues and also appropriately manage upward
• Ability to successfully manage workload to timelines
• Ability to negotiate a strategic position after taking feedback from multiple sources
• Strong organizational skills, including ability to follow assignments through to completion
• Enhanced skills in leading, influencing, and negotiating.
• Experience with processes involved in manufacturing and distribution, QA, QC, validation, and processes development
• Ability to interact effectively with regulatory agencies
• Strong word processing, presentation, database and spreadsheet application skills
• Excellent communication and executive presence (both written and oral), facilitation and presentation skills
• Strong skill in working independently and to effectively interact with various levels
• Skilled in risk management
• Project management skills
• Ability to travel +/- 20% of time to domestic and international Amgen sites

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

• Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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