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Sr Associate QA

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Amgen

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Location:
China , Shanghai

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

The International & Distribution Quality (IDQ) team supports products to and in the market after our manufacturing sites have produced high-quality medicines for our patients. The China IDQ team is a commercial-facing group that has oversight over finished drug product distribution in China. This oversight includes business partners, Logistics service providers, distributors, wholesalers, contract packaging, import testing laboratories product complaints, and Affiliate QMS to ensure our products are safe and effective. The Senior Quality Associate is responsible for leading and conducting the following Quality Assurance activities to support China GSP/GMP requirements as well as JAPAC regional activities where required.

Job Responsibility:

  • Support activities to maintain the quality system and execute tasks in compliance with Amgen’s Quality Management System, GDP/GMP requirements and any local applicable regulations
  • Completes required assigned training to permit the execution of required tasks
  • Conduct GSP remote and on-site Due diligence visit and/or Inspection, may extended to GMP related
  • Alerts any quality, compliance, supply and safety risks
  • Ensures that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements
  • Conduct Product complaint outbound work per the guidelines, such as reconciliation of Product complaint samples
  • Provide quality guidance for commercial programs including patient support programs and Product Complaint training
  • Consolidation of information on complaint sample returns and replacements. Handling of complaint‑related OBT activities. Tracking and follow‑up of complaint return samples
  • Updating and maintenance of complaint training materials. Continuous optimization of complaint‑related communication and responses in collaboration with cross‑functional teams across Amgen China
  • Provide support for supplier onboarding. Submission of payment requests for reagents
  • Communicate with Logistics service partners and cross-functional departments for routine tasks, and physical visit to LSP/distributors
  • Manage documentation and the archive of all the relevant documents
  • Support Company Secretarial affairs when needed
  • Implement continuous improvement practices and work hard to meet organizational objectives
  • Performs review and tracking of cGMP/GDP and QMS processes documents and records
  • Experienced in planning, organizing and problem-solving to complete multiple deadline-driven projects efficiently and on time

Requirements:

  • Bachelor’s degree in pharmacy or related majors
  • Above 3-5 years experience in a pharmaceutical company
  • preferred to have quality function experience in a distribution company, manufacturing site and/or auditing function
  • Has knowledge of local regulations related to Good Distribution/Supply Practice (GDP/GSP) and Good Manufacturing Practices (GMP)
  • Good written and spoken English and Mandarin
  • Strong project and time management skills
  • ability to plan tasks and timetable in advance
  • Patient, be able to work independently and under pressure
  • Strong initiative, mature, attentive to details and a good team player
  • Problem solving

Nice to have:

  • Overseas education is preferred
  • preferred to have quality function experience in a distribution company, manufacturing site and/or auditing function

Additional Information:

Job Posted:
May 04, 2026

Employment Type:
Fulltime
Work Type:
Hybrid work
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