Associate Quality Control
2 weeks ago
Career Category
Quality
**Job Description**:
Associate Quality Control
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 Quality Control in Amgen Singapore Manufacturing, Singapore.
Associate Quality Control
Live
What you will do
Main responsibilities:
- 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
- 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 in Chemistry, Biochemistry, Life Science or related technological field and 2 years of directly related experience OR
- Associate’s Degree in Chemistry, Biochemistry, Life Science or related technological field and 4 years of directly related experience OR
- 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, ICP, LOD, Auto-titration, KF, Optical Rotation, wet chemistry, FT-IR, pH, conductivity, TOC, Potency, ELISA, Capillary Electrophoresis, DNA Testing).
- Analytical chromatography, Bioassay and/or Immunoassay experience preferred for this role.
- 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 run multiple simultaneous activities in a constantly evolving environment.
- Work on shift schedules may be required.
Thrive
What you can expect of us
As we work to develop treatments that take care of others so 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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