Amgen QC Lab Analyst I in Singapore, Singapore
Quality Control Professional with background and experience in commercial production and testing of GMP active pharmaceutical ingredients (API)
Work in a cross functional team with Process Development, Manufacturing, Supply Chain, Engineering and Facilities to ensure product quality and market supply
Experiences in lab equipment such as HPLC/UPLC, GC/GC-HS, ICP-MS, LOD, Autotitration, KF, Optical Rotation, Wet chemistry, Spectrophotometry (FT-IR), pH, conductivity, TOC, etc.
Experiences in lab system such as Empower, LIMS, Trackwise, etc.
Involved in trending of laboratory data on periodic basis
Involved in compendial review and updates for methods
Attend teleconference from Amgen network/global (off office hours)
Involved in troubleshooting/investigation of issues in manufacturing/laboratory
Participate in continuous improvement initiatives and projects.
Any other tasks assigned by the supervisor/QC Manager
Education / Licenses
Degree in Chemistry or related technological field, or
Diploma in Chemistry related technological field.
- 3 years of relevant work experience in the commercial manufacturing environment within the pharmaceutical industry, API chemical production and analytical testing experience preferred.
Competencies / Skills
Must have practical knowledge and understanding of GMP pharmaceutical API production, API plant operation and associated testing methods.
Advanced knowledge and depth of experience with Quality Control testing and GMP laboratory operations for common pharmacopeia testing methods and equipment (HPLC, wet chemistry, Gas Chromatography, Residual Solvents, Liquid Chromatography-Mass Spec, Heavy Metals, Bioburden, Endotoxin)
GMP laboratory operation including development and management of systems for equipment qualification, method validation, sample management, data management, trending and OOS investigations
Experience in method qualification and transfers
Good communication skills (technical writing and verbal communication/presentation)
Interact effectively with cross functional team
Problem solving skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality