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.
Raw Material DispositionLive
What you will do
Lets do this! Lets change the world! In this vital role, you will be responsible for Disposition of Raw Materials, deviation management and quality oversight. This position provides the opportunity to work directly with Supply Chain, Shipping, External Supply and Procurement for the incoming raw materials. As a Sr. Associate you will also facilitate real-time decision-making regarding quality requirements and deviations. This is a unique opportunity to foster a strong partnership and learning environment between Supply Chain/Warehouse, External Supply and Disposition Quality staff. Amgens Raw Material Disposition provides coaching, guidance and direction to Supply Chain, Warehouse, Procurement and our PQA Partners coordinating Manufacturing Operations. In this role, you will be responsible for the following in regard to compliance and quality systems:
- Provides Quality oversight to ensure that products are manufactured, tested, stored, and distributed according to current Good Manufacturing.
- Ensures Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.
- Ensures that facilities, equipment, materials, organization, processes, procedures and products stay in sync with cGMP practices and other applicable regulations.
- Performs review and approval of cGMP processes, procedures, documents and records, including but not limited to Nonconformance, Corrective Action/Preventative Actions (CAPA), Change Control records and validations, Raw Materials and Drug Substance documentation.
- Author/review/approve quality documents, such as: SOPs, user requirements, risk assessments, training materials, and protocols/reports.
- Establishes and enables LEAN practices. Drives Operational improvement initiatives, programs and projects.
- Oversees and provides mentorship of the Raw Material Reject Cage.
- Ensures that changes that could potentially impact product quality are assessed according to procedures.
- Ensures that deviations from established procedures are investigated and detailed per procedures.
- Ensures that raw material batch packets and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
- Alerts senior management of quality, compliance, supply and safety risks.
- Completes required assigned training to permit execution of required tasks.
- Drives operational improvement initiatives, programs and projects.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The experienced professional we seek is a problem solver with these 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
- Strong cGMP and GDP behaviors
- Previous QA oversight of manufacturing or raw material warehouse
- Strong organizational skills and ability to manage multiple tasks at one time
- Experience in Raw Material or External Supplier Quality
- Experience in deviations, investigations, change controls, and CAPAs processes system knowledge
- Experience and training in EDMQ, Trackwise, Maximo, LIMS
- Experience in managing multiple, competing priorities in a fast-paced environment teams
- Direct bulk drug substance and drug product experience
- Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff
- Ability to solve complex problems and make scientific risk-based decisions
Some of the vast rewards of working here
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.
- 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
for a career that defies imagination
Objects in your future are closer than they appear. Join us.careers.amgen.com
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.