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Associate Mfg - AML 14

Employer
Amgen
Location
Juncos, PR, US
Start date
Sep 14, 2019

View more

Discipline
Engineering, Science/R&D, Biotechnology, Pharmacology
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Best Places to Work

Job Details

SUMMARY

The Associate Manufacturing role will support the Drug Product Filling operations according to Standard Operating Procedures (SOPs). Will perform and monitor 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 NC/CAPA's. May identify, recommend, and implement improvements related to routine functions in a Non-Standard Shift environment. Several positions available.

SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

 

  • Hands-on operations, set-up, clean, sanitize and prepare room and equipment for the Filling Process
  • Perform and monitor critical filling processes
  • Execute routine validation protocols
  • Comply with GMP's
  • Regularly draft and revise routine documents (e.g. MPs, SOP's, and technical reports)
  • Initiate Quality incidents
  • Identify and recommend improvements related to routine functions and implement after approval
  • Basic troubleshooting
  • Recognize & accurately report problems
  • Assist in the review of documentation for assigned functions (e.g. manufacturing orders, routine area audits, batch records)
  • May work generating/receiving inventory orders
  • May train staff to perform hands-on tasks
  • May act as safety representative
  • May assist with system ownership responsibilities

 


BASIC EDUCATION & EXPERIENCE

Bachelor's degree

PREFERRED QUALIFICATIONS

 

 

 

  • Educational background in Life Sciences or Engineering
  • Availability for Non Standard Shift
  • Experience in biotechnology, pharmaceutical or medical device company
  • Understand equipment/processes which leads to greater independent judgment
  • Basic mathematical skills
  • Excellent communication skills
  • Technical writing capability
  • GMP knowledge with ability to interpret & apply
  • Interaction...seek outside resources as needed
  • Understand analytical methods for manufacturing area
  • Specific system/equipment skills
  • Basic project management skills

 


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.

Join Us

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.

 

 

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Company info
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States

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