About the role

AI summarised

Senior Associate Quality Control I (Chemistry) at Amgen Singapore Manufacturing, a leading biotechnology company. The role involves performing quality control testing of raw materials, in-process samples, and finished products using analytical chemistry techniques in a GMP environment.

BiotechFull-timeQuality

Key Responsibilities

Perform routine and non-routine testing of raw materials, in-process samples, and finished products using analytical chemistry techniques.
Execute and document laboratory tests in compliance with GMP and regulatory requirements.
Review and approve test results, ensuring accuracy and completeness.
Participate in method transfer, validation, and troubleshooting activities.
Maintain laboratory equipment and ensure proper calibration and maintenance.
Support investigations of out-of-specification results and deviations.
Contribute to continuous improvement initiatives in the QC laboratory.
Prepare and review standard operating procedures (SOPs) and other quality documents.

Requirements

Bachelor's degree in Chemistry, Biochemistry, or related scientific field.
Minimum 3 years of experience in a quality control laboratory within the pharmaceutical or biotechnology industry.
Strong knowledge of GMP and regulatory requirements.
Proficiency in analytical techniques such as HPLC, GC, UV-Vis, and wet chemistry.
Experience with laboratory information management systems (LIMS).
Excellent attention to detail and documentation skills.
Ability to work independently and as part of a team.
Strong problem-solving and analytical skills.
Effective verbal and written communication skills.