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Manager Quality Control (Micro and Sample Management)

Singapore, Singapore Employment contract · Job Posted June 28, 2026
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Job Description

Manager Quality Control (Micro and Sample Management) at Amgen Singapore Manufacturing. In this vital role, you will be responsible for QC Microbiology Shift teams. Responsibilities include leading and supervision of staff, maintenance of the weekly lab schedule and prioritization of daily work tasks. Providing Quality oversight to ensure that processes are followed in accordance to current Good Manufacturing Practices (cGMP). The Manager will ensure that facilities, equipment, materials, organization, processes, procedures and products align with cGMP practices and other applicable regulations. Perform review, approval and tracking of cGMP processes, procedures, documents and records, including but not limited to nonconformance records and CAPAs.

Job Responsibility

  • Lead and supervise QC Microbiology Shift teams
  • Maintain the weekly lab schedule and prioritize daily work tasks
  • Provide Quality oversight to ensure processes follow cGMP
  • Ensure facilities, equipment, materials, organization, processes, procedures and products align with cGMP
  • Perform review, approval and tracking of cGMP processes, procedures, documents and records including nonconformance records and CAPAs
  • Oversee day to day activities in microbiology (routine environmental & utilities monitoring
  • raw material and product testing such as bioburden, microbial limits test, endotoxin, qPCR, microbial ID
  • media, reagent and culture qualification such as growth promotion
  • etc.)
  • Oversee sample management and stability (sample logging, receipt and processing, sample aliquoting, movement and storage of samples, stability initiations and time point pulls, etc.)
  • Collaborate with the global Amgen QC network
  • Provide on-site support and collaboration for both biologics and small molecule manufacturing
  • Present the QC Microbiology lab area during audits and inspections
  • Act as Functional Area Owner for microbiology testing, stability processing and shipment deviations
  • Oversee Microbiology laboratory investigations
  • Lead laboratory troubleshooting and problem-solving exercises
  • Manage Contract Test Lab sample lifecycle (purchase orders to results)
  • Oversee LIMS Lot Authorization and on-time lot disposition deliverables
  • Ensure compliance with safety guidelines, cGMPs and other applicable regulatory requirements
  • Support staff training, career development and performance management
  • Support site and global initiatives
  • Support implementation of new equipment and technologies
  • Support Continual Improvement and LEAN initiatives, programs and projects
  • Ensure changes that could potentially impact product quality are assessed according to procedures
  • Ensure deviations from established procedures are investigated and documented per procedures
  • Ensure records are complete, accurate, and documented according to written procedures and cGMP requirements
  • Collaborate cross functionally as needed to ensure the Quality Management System processes are executed in accordance with established procedures
  • Alert senior management of quality, compliance, supply and safety risks
  • Represent the quality unit during audits and inspections
  • Support internal/external audits and inspections as part of the audit/inspection management team

Requirements

  • Doctorate degree
  • OR Master's degree and 2 years of Quality or Operations related experience
  • OR Bachelor's degree and 4 years of Quality or Operations related experience
  • OR Diploma and 8 years of directly related experience
  • Strong knowledge and understanding of microbiology testing methodology and strategy for contamination control
  • Knowledge and experience with general GMP laboratory operations, data integrity requirements and associated laboratory equipment
  • Experience with computerized laboratory information management systems, electronic laboratory notebooks and other QC analytical equipment
  • Ability to lead diverse teams
  • Good communication skills (technical writing and verbal communication/presentation)
  • Ability to work in cross-functional and multisite teams
  • Interact effectively with variety of communication and working styles
  • Problem solving skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality

What we offer

  • Vast opportunities to learn and move up and across our global organization
  • Diverse and inclusive community of belonging
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

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