Associate Quality Control

Associate Quality Control I
Amgen Singapore Manufacturing
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 Control I in Amgen Singapore Manufacturing .
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Responsibilities
Support 12-hour rotating day shift (8am-8pm), inclusive of weekends and public holidays.
Responsibilities may include but are not limited to:
Execute testing and/or review, such as routine environmental, water, raw material and product testing (e.g. bioburden, endotoxin, qPCR, microbial ID etc.); media, reagent and culture qualification (e.g. growth promotion, DNA positive controls, microorganisms culture types etc.).
Sample management which includes logging of samples, movement and storage of samples, reconciliation of sample receipt, aliquoting of samples, management of stability samples, and shipment of samples to Amgen network sites and/or contract labs.
Involvement in document revisions and report writing.
Involvement in equipment installation commissioning and qualification, calibration and maintenance.
Involvement in method transfers, method validation/verification and sample type qualification.
Laboratory housekeeping and document archival.
Project management / Involvement in QC projects (e.g. Continuous Improvement/ Operational Excellence)
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodation for additional tasks and responsibilities.
Qualifications
Bachelor’s degree in Microbiology, Biological Sciences, Life Sciences or related technological field and 2 years of directly related experience OR
Associate’s Degree in Microbiology, Biological Sciences, Life Sciences or related technological field and 4 years of directly related experience
High School Diploma in Microbiology, Biological Sciences, Life Sciences or related technological field / GED and 6 years of directly related experience
1-3 years of relevant professional work experience within the pharmaceutical or biopharmaceutical industry, biopharmaceutical production and testing experience preferred.
Knowledge and understanding of GMP pharmaceutical production, pharmaceutical plant operation and associated testing methods.
Experience with Quality Control testing and laboratory operations for common microbial testing methods and equipment (e.g. including but not limited to bioburden, endotoxin, microbial identification, environmental monitoring, microbial limits, growth promotion, biological indicators).
GMP laboratory operation including conducting sample management and testing.
Good communication skills (technical writing and verbal communication/presentation).
Interact effectively with variety of communication and working styles and ability to work well in teams.
Ability to manage multiple simultaneous activities in a rapidly changing environment
Problem solving skills with the ability to apply logic and assess data to reach decisions and solutions related to assay suitability and comparability.
Benefits
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
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.
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.
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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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