Amgen offers the opportunity to be at the interface between research, global development and manufacturing to ensure that these molecules become medicines. Many of the technologies we're employing are not only new to Amgen but are new to the industry as a whole. Help us to pave new roads for helping oncology patients.
The Specialist Quality Assurance position will be responsible for the following activities:
Responsible for supporting validation activities with QC's analytical testing equipment and analytical systems.
Site business process management of QC analytical systems, such as LMES, CIMS and Empower.
Responsible for templating and/or qualification activities, aligned to source documentation.
Site lead and SME with Corporate QC and IS Networks, supporting holistic oversight of the management, improvement and troubleshooting of QC's analytical systems.
Responsible for data queries from QC's electronic systems.
Responsible for management and oversight of GMP activities in assigned Operations function.
Responsible for QC Assessor for Change Controls impacting analytical systems.
Provide QA oversight to document management of various processes within QC
Supports inspection readiness activities across Quality Control, and site audits and inspections.
Provide subject matter expertise to nonconformance investigations, corrective and preventive actions, and change control records.
Supports Continual Improvement initiatives, programs and projects
o Doctorate degree
o Master's degree and 3 years of Quality experience
o Bachelor's degree and 5 years of Quality experience
o Associate's degree and 10 years of Quality experience
o High school diploma / GED and 12 years of Quality experience
o Experience with Analytical Systems (ie. SM LIMS, CIMS, Empower, LMES)
o Validation experience (Lab equipment, computer related systems)
o Project management
o Proficiency in Excel, Word, and Power Point
o Strong interpersonal skills
We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.
Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.
We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
If 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. Associated topics: automation, performance test, process, prevent, quality assurance engineer, software quality assurance, software quality engineer, software quality assurance engineer, test, tester