Amgen QC Lab Analyst I in Singapore, Singapore

Role Description:

  • 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.

Relevant Experience

  • 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