AddressHOW MIGHT YOU DEFY IMAGINATION?
You’ve 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 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. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Sr Associate Manufacturing - External Supply Raw Material and Devices Quality Record Owner
Live
What you will do
Let’s do this. Let’s change the world. In this vital role you will own and implement under minimal supervision all processes related to Supplier Event Notifications, Supplier Investigations (EN/SICAR), and Change Control quality records. In addition, you will apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support quality records originating from manufacturing sites across the Amgen network.
Responsibilities include, but are not limited to the following:
Address and close quality records under the company's quality management system procedures and ensure compliance with regulatory agency requirements.
Complete assignments according to current business policies, operational procedures, and within established metrics
Act as the External Supply representative across functional teams to achieve robust and detailed investigation performance and drive closure of quality records in a timely manner
Support investigation teams to identify meaningful supplier root causes and robust supplier corrective and preventative actions by effectively applying root cause analysis tools (Causal Factor Analysis, Fault Tree Analysis, Kepner-Tregoe, etc.)
Work closely with the suppliers and External Supply peers to address and close critical investigations and Corrective Actions
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Sr Associate Manufacturing - External Supply RMD QRO professional we seek is an individual contributor with these qualifications:
Basic Qualifications:
Bachelor’s degree and 6 month of manufacturing and/or quality experience
Or
Associate’s degree & 2 years manufacturing and/or quality experience
Or
High school diploma / GED & 4years manufacturing and/or quality experience
Preferred Qualifications:
2+ years work experience (manufacturing and/or quality assurance) in Biotech or pharmaceutical industry with progressively increasing responsibility and demonstrated experience in compliance, problem solving, critical thinking, project management, and quality systems.
Demonstrated ability to coordinate and effectively participate in cross-functional project teams and deliver on schedule.
Experience in leading multiple, contending priorities in a fast-paced environment with minimal direction.
Excellent communication skills, both written and verbal in English (including technical writing and presentation skills) with ability to collaborate productively with technical and senior management staff.
Strong Demonstrated ability to work autonomously, present data in an organized and logical manner, meet deadlines, prioritize work and communicate effectively.
Demonstrated ability to navigate through ambiguity and provide a structured problem-solving approach.
Proficient with Microsoft Office Tools (Word; Excel; PowerPoint; Project, Teams, Outlook)
Interpersonal and facilitation skills necessary to forge consensus among challenging client interests while ensuring objectives are met.
Demonstrated ability to deliver results through living the Amgen values.
Ability to maintain remote working relationships with colleagues at other Amgen sites.
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.
In addition to the base salary, 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
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 an annual site shutdown
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.
