Associate QA I - Singapore - Amgen

Amgen

Verified Company

Singapore

2 weeks ago

Posted by:

Wei Jie

beBee Recruiter

Description

Associate Quality Assurance (PQA)

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 QA(PQA) in
Singapore.

Associate Quality Assurance (PQA):

Live:

What you will do

Main Responsibilities:

Support the maturation and continuous improvement of Amgen quality systems, including Onthefloor quality oversight, deviation management, change control and ensure that the systems are managed in compliance with cGMP expectations
Participate in root cause investigations for nonconformances
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

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.

Win:

What we expect of you:

Qualifications:

Bachelor's Degree and 2 years of directly related experience OR
Associate's Degree and 4 years of directly related experience OR
High School Diploma / GED and 6 years of directly related experience
13 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
Ability and willingness to work any shift in support of operations that may include 24/7

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.