Associate quality control

1 month ago

Singapore Amgen SA Full time

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 (Microbiology) in Singapore. Associate Quality Control (Microbiology) What you will do We are seeking to appoint a well-qualified and experienced individual to assume the role of Associate Quality Control. Main Responsibilities : Support 12-hour rotating day shift (8am-8pm), inclusive of weekends and public holidays. Execute testing and/or review, such as routine environmental, water, raw material and product testing (e.g. bioburden, endotoxin, q PCR, microbial ID etc.); media, reagent and culture qualification (e.g. growth promotion, DNA positive controls, bioballs etc.). Sample management which may include 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. 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. operational excellence). What we expect of you 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. Diploma in Microbiology, Biological Sciences, Life Sciences or related technological field / GED and 6 years of directly related experience. Preferred 2 years of relevant professional work experience within the pharmaceutical or biopharmaceutical industry, biopharmaceutical production and testing experience preferred. Should have 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 a 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. 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. careers.amgen.com 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. #J-18808-Ljbffr

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