Senior Specialist QA - Corporate GxP Computerized Systems (Remote)
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.Live
What you will do
Lets do this! Lets change the world!
At Amgen, our mission is simple: to serve patients.
The Sr. Specialist Quality Assurance will lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved validation techniques and procedures.
This individual will actively participate during all phases of qualification/validation: evaluate projects; provide guidance and technical information to others (lead qualification/validation activities); determine and establish requirements for qualification/validation of each individual system/equipment; formulate independent decisions related to qualification/verification activities.Responsibilities:
Support a diverse team of Quality Professionals which span multiple time zones. Review validation/qualification packages for completeness and accuracy, sound rationale, Regulatory expectations, compliance with validation policies and procedures, and accurate data analysis. Compare results against acceptance criteria and work with appropriate departments to resolve exceptions and deviations. Bring critical exceptions or deviations to managements attention and initiate and enforce necessary improvements and corrections to established systems and processes.
Participation and support of regulatory inspections. The following are examples of execution tasks for this position:
Act as reviewer and approver for operational SOPs
Review and approve change controls and Deviations/CAPA/CAPA EVs
Initiate and own QA Deviations/CAPA/CAPA EVs (Major and Minor)
Review and approve System Life Cycle Documents (i.e. test protocols) before use in production.
Applies analytical skills to evaluate and interpret complex situations/problems using multiple sources of information
Forecasts, models and utilizes advanced analytical tools
Anticipates and prevents potential problems
May be responsible for specific programs and/or projects
Independently develops solutions that are thorough, practical and consistent with functional objectives
Establish/Improve training curriculum
Provide Management Review Updates on Quality activities
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek will have these qualifications.
Doctorate degree and 2 years of quality experience
Masters degree and 6 years of quality experience
Bachelors degree and 8 years of quality experience
Associates degree and 10 years of quality experience
High school diploma / GED and 12 years of quality experienceThrive
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.
Vast opportunities to learn and move up and across our global organization
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
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.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, 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.Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.
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