Specialist Quality Assurance

Specialist Quality Assurance
  
 
What you will do 
Let’s do this. Let’s change the world. In this vital role you will be serving patients through internal collaboration with Amgen’s global quality teams, manufacturing sites and external engagement with contract manufacturing organizations. You will make key contributions to ensure high quality and right first time materials are received at the Amgen, build a resilient supply network and conclude with a positive patient experience.
In this role you will be part of Amgen’s Global Supply Quality team supporting oversight and maintenance of contract manufacturers.
  
 
Roles & Responsibilities: 

Perform tactical batch disposition activities in support of lot release

Enter and approve analytical data in LIMS

Manage and drive Quality records to closure including deviation records, investigation reports

Initiate Quality records for supplier related changes.

Collaborate with Complaints team to request assessments, reviews complaint report and have comments addressed

Provide data to the networks to support Quality Management Processes)

Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.

Take part in operational and quality improvement initiatives, programs, and projects.

Communicate optimally with key collaborators, ensuring alignment on quality objectives and compliance needs.

  
 
What we expect of you 
We are all different, yet we all use our outstanding contributions to serve patients.


Basic Qualifications:

Doctorate degree OR

Master’s degree and 4 to 6 years of quality assurance experience OR

Bachelor’s degree and 6 to 8 years of quality assurance experience OR

Diploma and 10 to 12 years of quality assurance experience

Preferred Qualifications:


Must-Have Skills:

Working foundation in quality assurance roles.

Minimum of 4 years working in a cGMP manufacturing environment with a strong understanding of regulatory requirements and expectations.

Ability to have a positive impact on others; the ability to affect the behaviors of others by connecting with and encouraging them

Good-to-Have Skills:

Experience in investigations, project management and trending and analysis

Relevant experience in Supplier Management, raw materials, packaging components, and/or device manufacturing.

Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes).

Proven experience in designing and/or improving processes at conceptual level

Desire to partner with internal and external key collaborators across teams

Understanding of industry requirements/expectations of a robust Quality Management System and documentation.

Soft Skills:

Excellent analytical and troubleshooting skills.

Strong verbal and written communication skills

Ability to work effectively with global, virtual teams

High degree of initiative and self-motivation.

Ability to prioritize successfully.

Team-oriented, with a focus on achieving team goals

Strong presentation and public speaking skills.

  
 
What you can expect of us 
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
  
 
Apply now for a career that defies imagination 

Objects in your future are closer than they appear. Join us.
  
 
careers.amgen.com 

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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
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, disability status, or any other basis protected by applicable law.
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.