Associate QA

Career Category

Quality

**Job Description**:
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 QA in Singapore.

Associate QA

Live

What you will do

The Associate QA will be responsible for providing oversight for Quality on-the-floor and operations support, the Associate QA will support manufacturing operations and IPC testing through purposeful presence on the floor, and support of complex manufacturing investigations, change control, and unexpected result investigations. Required to perform 12-hour shift (rotational night and day, or full night shift as required due to business needs).

**Responsibilities**:
- Support the maturation and continuous improvement of Amgen quality systems, including On-the-floor quality oversight, deviation management, change control and ensure that the systems are managed in compliance with cGMP expectations- Participate in on the floor triage and support root cause investigations for major investigation if applicable.- Review and approve minor deviation, change controls, and other quality 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- Escalate any significant event to Quality management in a timely manner

Win

What we expect of you

**Qualifications**:

- Bachelor’s Degree in Science and 2 years of directly related experience OR- Associate’s degree in Science and 4 years of directly related experience OR- High school diploma/GED in Science and 6 years of directly related experience- Fluency in written and spoken English- 1-4 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.- 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

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

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.

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