Amgen Sr 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) and Biologics products
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), SoloVPE, pH, conductivity, TOC, PCR, EndoPTS, etc.
Management of calibration/PM for lab equipment in the laboratory
Experiences in lab system such as Empower, CIMS, LIMS, LMES, Trackwise, etc.
Involved in trending of laboratory data (Chemistry/Micro) on periodic basis
Involved in compendial review (Chemistry/Micro) and updates for methods
Attend teleconference for Amgen network/global meeting (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.
- > 5 years of relevant work experience in the commercial manufacturing environment within the pharmaceutical or Biologics 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 technical knowledge on different testing methods.
Some knowledge and 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 laboratory assest management, method validation and transfers
Train and mentor peers
Interact effectively with cross functional team
Some problem solving skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality