Senior 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 Senior Associate QA in Singapore.

Senior Associate QA

Live

What you will do

The Senior Associate QA will be required to perform 12-hour shift (rotational night and day, or full night shift as required due to business needs).

Main Responsibilities:

- Quality Professional with background and experience in commercial production of Biological drug substance to oversee night shift or day shift operations as required.
- Conduct Quality Assurance activities related to quality floor support for solution and equipment preparation, cell culture and product purification & Drug Substance Filling operations.
- Support of electronic batch record review and approval, change control, investigations and product release
- Work in a cross functional team with Process Development, Manufacturing, Supply Chain, Engineering and Facilities to ensure product quality and market supply
- Role may include participation in new product introductions, additional equipment, installation commissioning, qualification.
- Support continuous improving initiatives

**Qualifications**:

- Master’s degree in Science or
- Bachelor’s degree in Science and 2 years of directly related experience
- Associate’s degree in Science and/or 6 years of directly related experience
- High school diploma in Science / GED and 8 years of directly related experience
- Preferred 5+ years of relevant work experience in the commercial manufacturing environment within the pharmaceutical / biologics industry and understanding of GMP pharmaceutical production, biological drug substance experience and operation
- Experience with batch record review, and quality record support
- Experience in pharmaceutical equipment operation, design and control including GMP change control
- Experience in providing floor support, troubleshooting unit operations, and resolving and documenting investigations to support cGMP production
- Understanding of equipment log review and continuous monitoring requirements
- Good communication skills (technical writing and verbal communication/presentation)
- Interacts effectively with variety of communication and working styles
- Experience with regulatory audits and inspections

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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