Associate Mfg - AML14 Formulation
Amgen
2021-12-03 07:39:03
Rico, Colorado, United States
Job type: fulltime
Job industry: I.T. & Communications
Job description
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.
Associate Mfg - AML14 Formulation
LiveWhat you will do
Lets do this. Lets change the world. In this vital role you will support the Formulation and Filling operations according to Standard Operating Procedures (SOPs). Will perform and supervise critical processes, execute routine protocols, and regularly draft and revise documents such as Manufacturing Procedures and SOPs. Perform basic troubleshooting and assist in the review of documentation for assigned functions. May participate on cross-functional teams. Employee may also have the responsibility of owning Deviations/CAPAs. May identify, recommend, and implement improvements related to routine functions in a Non-Standard Shift environment.
Specific responsibilities include but are not limited to:- Hands-on operations, set-up, clean, sanitize and prepare room and equipment for the Formulation and Filling Process, including Buffer preparation and formulation.
- Perform and supervise critical filling processes.
- Implement routine validation protocols.
- Perform Tanks and equipment cleaning, assembly and sterilization.
- Receive, store, dispense, deliver, transfer, reconcile, cycle count, or ship materials per cGMP procedures and regulations.
- Operate multiple inventory software applications and resolve basic system issues within Amgens SAP and MES system
- Operate warehouse equipment, e.g. pallet jack, etc.
- Regularly draft and revise routine documents (e.g. MPs, SOPs, and technical reports)
- Assist in the review of documentation for assigned functions (e.g. manufacturing orders, routine area audits, batch records)
- Initiate Quality Deviations
- Identify and recommend improvements related to routine functions and implement after approval
- Conduct Basic troubleshooting
- Recognize & accurately report problems
- May work generating/receiving inventory orders
- May train staff to perform hands-on tasks
- May act as safety representative
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Associate Mfg. Professional we seek is an individual contributor with these qualifications.
The Basic Qualifications are:Bachelor's Degree
Beyond that, the additional preferred qualifications are:- Educational background in Life Sciences, Biotechnology or Engineering
- Availability to Support Non-Standard Shifts including rotative weekdays and weekends
- Experience working in a GMP biotechnology, pharmaceutical or medical device company
- Proficient experience performing assembling disassembling, operating, and understanding equipment per procedures.
- Knowledge of basic computer systems including Microsoft Office, SAP, MES, LIMS.
- Organization skills and talent to perform assignments with a high degree of attention to detail.
- Capacity to follow written procedures, recognize and report malfunctions and adjust equipment.
- Knowledge in Aseptic Techniques
- Understand equipment/processes which leads to greater independent judgment
- Basic mathematical skills
- Excellent communication skills
- Technical writing capability
- Basic project management skills
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
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
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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.