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Form of workHOW MIGHT YOU DEFY IMAGINATION?
Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Senior Associate Quality Complaints
Live
What you will do
Lets do this! Lets change the world! Lets do this! Lets change the world! The Senior Associate Quality Complaints at Amgen plays a crucial role in maintaining high-quality standards across Product Complaints & Surveillance. They investigate product complaints to ensure a thorough and robust investigation is performed while ensuring compliance with internal procedures and external regulations. The Sr. Associate conducts low to medium complexity complaint investigations and determines if complaint investigations require escalation for further investigation.
Key Responsibilities:
Ensure product complaint records are processed according to FDA guidelines, SOPs and other regulatory agencies guidelines.
Ensures quality of complaint records
Applies analytical abilities to evaluate complex situations using multiple sources of information
Provides feedback and guidance to improve quality performance and prevent recurrence of issues
Develops solutions to technical problems of moderate complexity
Screens, evaluates, reports and resolves record integrity issues
Raises potential Quality issues to Management
Manages complaint records and performs task in a timely manner; acting with a sense of urgency
Basic Qualifications
Masters degree OR
Bachelors degree and 6 months of Quality experience OR
Associates degree and 2 years of Quality experience OR
High school diploma / GED and 4 years of Quality experience
Preferred Qualifications
Quality and manufacturing experience in biotech or pharmaceutical industry
Bachelors Degree in a Science Field
Ability to successfully manage workload to timelines
Familiarity with basic project management tools
Demonstrated ability to consistently deliver on-time, and high-quality results
Ability to operate in a matrixed or team environment
Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
Thrive
What you can expect of us
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.
Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
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 and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
