Associate Quality Assurance I

4 weeks ago

Singapore Amgen Full time

Associate Quality Assurance (TQA)

Singapore

HOW MIGHT YOU DEFY IMAGINATION?

Amgen is one of the world's leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring an Associate Quality Assurance (TQA) in Singapore .

Associate Quality Assurance (TQA)

Live

What you will do

The candidate will be responsible for providing oversight for Quality on-the-floor and operations support, as well as supporting the manufacturing operations and IPC testing through purposeful presence on the floor, and support of complex manufacturing investigations, change control, and unexpected result investigations.

Responsibilities:

  • Support the maturation and continuous improvement of Amgen quality systems, including On-the-floor quality oversight, raw materials release, non-conformances, change control and CAPA and ensure that the systems are managed in compliance with cGMP expectations
  • Participate in root cause investigations for non-conformances
  • Review of nonconformance investigations, change controls, and other quality records (with focus on highly complex records) such as electronic batch records, SOPs, logbooks and work orders
  • Support in regulatory inspections, and interact directly with regulatory inspectors
  • Supporting other QA initiatives/activities such as continuous improvement projects, supplier quality, stability program, product quality review, customer complaint investigation

Win

What we expect of you

Qualifications

  • Bachelor's Degree and 2 years of directly related experience OR
  • Associate degree and 4 years of directly related experience OR
  • High school diploma/GED in Science and 6 years of directly related experience
  • 1-3 years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical/biopharmaceutical industry with progressively increasing responsibility and demonstrated experience in quality assurance, and quality systems.
  • Direct experience with bulk manufacturing of biopharmaceuticals preferred.
  • Ability to work independently in a fast paced / dynamic work environment
  • Good time management skill, great attention to detail, ability to manage multiple projects.
  • Proficient presentation and facilitation skills

Your selection for this role will be subject to fulfilling the medical requirements of this job scope. If so, you will be informed of the medical check(s) that you may need to undergo. All medical related expenses incurred from this medical check shall be borne by the company.

Thrive

What you can expect of us

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.

  • Vast opportunities to learn and move up and across our global organization
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

Equal 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.


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