HOW MIGHT YOU DEFY IMAGINATION?
Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.Live
What you will do
Lets do this! Lets change the world!
Responsible for management and oversight of GMP activities in assigned Operations function.
Ensures that products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution
Practices (GDP) and other applicable regulations and specifications
Ensures that manufacturing facilities, equipment, processes, and procedures are compliant with cGMP requirements and/or other applicable regulations
Ensures GMP activities for assigned Operations function follow approved GMP procedures and are documented according to cGMP and/or GDP requirements.
May also execute these GMP tasks
Responsible for ensuring that risks are identified, assessed and corrected to ensure the safety, purity, quality, and effectiveness of the product(s) manufactured
If managing staff, ensures that there is an adequate number of personnel who possess an adequate combination of education, experience and training in accordance with cGMP requirements
Ensures that area staff are trained to perform assigned GMP activities
Ensures that written procedures describing the instructions to execute GMP activities are controlled, approved and followed
May be required to own or provide subject matter expertise to nonconformance investigations, corrective and preventive actions, change control records or validations
Ensures that non-conformances for areas of responsibility are reported promptly to the Quality unit and investigated per procedures
Ensures that corrective actions and preventive actions (CAPA) are managed and closed according to procedures
Completes required assigned training to permit execution of required tasks
Ensures the requirements of the Quality Management System are fulfilled
Ensure controlled documents for the area of responsibility that require periodic review have an active owner assigned.
Ensure document periodic review activities are completed on time for documents owned by assigned areas of responsibility.
Alerts senior manager of significant quality, compliance, supply and safety risks
Provides input for Management Reviews
Supports Continual Improvement initiatives, programs and projects
Additional detail responsibilities, accountabilities or decision authorities are defined in
procedures to execute assigned task for the role and deployed through assignment of
procedure training in the Learning Management System.Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The vital attribute professional we seek will have these qualifications.
Masters degree and 2 years of Maintenance experience
Bachelors degree and 4 years of Maintenance experience
Associates degree and 10 years of Maintenance experience
High school diploma / GED and 12 years of Maintenance experienceThrive
Some of the vast rewards of working here
As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.
Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
Objects in your future are closer than they appear. Join us.
#Operations21Equal Opportunity Statement
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 a 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 an accommodation.
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 and Puerto Rico 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.