Senior Associate Qa

Career Category
Quality
Job Description
HOW 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.
Senior Associate QA
Live
What you will do
Let's do this. Let's change the world. In this role as Senior Associate QA, you will be working in a shift system; you will be mainly responsible for providing QA guidance and support to ATO Drug Substance production. Next to that, you will provide support in different QA related projects/systems. In this role, you will be in direct contact with a wide range of partners, and you will be accountable for establishing effective working relationships with production operators, production line leads, production shift supervisors, warehouse, facilities, maintenance and engineering. This role will require local presence at the ATO site.
Responsibilities:

• Provide daily guidance and support to Production staff regarding compliance with Standard Operating Procedures and Work Instructions.
• Ensure purposeful presence in drug substance areas to provide oversight to GMP operations and quality systems.
• Act as a first point of contact in case of production queries (quality related) during DS operations.
• Lead, mentor, and coach Operations and support personnel on quality matters, while driving the site Quality culture.
• Review and approve batch production record and other GMP documentation in support of daily operations. data entries before production activities take place
• Compile and review batch records for lots manufactured in preparation for batch disposition.
• Own, review, and approve controlled documents, including Standard Operating Procedures (SOPs), Work Instructions and Forms

Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a go getter with these qualifications.
Basic Qualifications:
Master's degree
Or
Bachelor's degree and 2 years of Quality experience
Or
Associate's degree and 6 years of Quality experience
Or
High school diploma / GED and 8 years of Quality experience
Preferred Qualifications:

• Quality and manufacturing experience in biotech or pharmaceutical industry
• Bachelor's 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

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.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
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.
Salary Range
83,842.00 USD - 98,328.00 USD