SENIOR ASSOCIATE QA

Join Amgens Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are.
Our shared missionto serve patients living with serious illnessesdrives all that we do.
Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases.
With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year.
As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based.
If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team.
Join us and transform the lives of patients while transforming your career.
Senior Associate QA What you will do Lets do this.
Lets 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 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:
High school/GED 4 years of Quality experience OR Associates 2 years of Quality experience OR Bachelors 6 months of Quality experience Master's 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 What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being.
From our competitive benefits to our collaborative culture, well support your journey every step of the way.
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.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:
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, including remote and hybrid work arrangements, where possible Apply now for a career that defies imagination Objects in your future are closer than they appear.
Join us.
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Application deadline External/Internal postings:
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
As an organization dedicated to improving the quality of life for people around the world, 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.
Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
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.