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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 (Analytical) in Amgen Singapore Manufacturing.
Job Responsibility:
Perform analytical testing of in-process control, drug substance intermediate, final release, stability and plant cleaning samples in a GMP pharmaceutical environment
Support laboratory operations including but not limited to equipment qualification, calibration, cleaning and maintenance, reagent/ buffer preparation
Responsible for maintenance of chemicals and consumables inventory
Ensure proper handling, storage, disposal of all chemicals used in the lab
Responsible for laboratory housekeeping and document archival duties
Participate in laboratory investigations and assist in timely closure of investigations, CAPAs and deviations
Participate in method verification and method validation/ transfer for new product introduction (when required)
Perform review of laboratory data/ records
Assist in SOP/ protocol/ report writing
Assist in periodic review of laboratory procedures and risk assessment
Support audit preparation and any audit related activity
Participate in continuous improvement initiatives and projects
Any other tasks assigned by the QC Manager
Work on shift schedules may be required
Requirements:
Bachelor’s Degree in Chemistry, Biochemistry, Life Science or related technological field and 2 years of directly related experience
Associate’s Degree in Chemistry, Biochemistry, Life Science or related technological field and 4 years of directly related experience
High School Diploma in Chemistry, Biochemistry, Life Science or related technological field / GED and 6 years of directly related experience
1-2 years of relevant laboratory experience in the commercial manufacturing environment within the pharmaceutical or biopharmaceutical industry and analytical 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 testing methods and equipment (e.g. including but not limited to UPLC, HPLC, LC-MS, GC-HS, LOD, Auto-titration, KF, Optical Rotation, wet chemistry, FT-IR, pH, conductivity, TOC, Potency, ELISA, Capillary Electrophoresis, DNA 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 and troubleshooting skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality
What we offer:
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
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