CrawlJobs Logo
Amgen Logo Amgen · Quality Control

Sr Associate QA

China, Shanghai · Job Posted May 04, 2026
Apply Position
Job Link Share

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
Amgen - All Job Offers

Looking for more opportunities?

Search for other job offers that match your skills and interests.

Suggested Tags: Frontend Developer Secretary Talent Manager Salesforce Administrator Data Analyst
Similar Jobs for

Sr Associate QA

8 matching positions

Sr Associate QA I

Sr Associate QA I at Amgen in Holly Springs, North Carolina. This is an on-site ...
Location
Location
United States , Holly Springs
Salary
Salary:
82081.95 - 111052.05 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High school/GED + 4 years Quality Assurance, manufacturing and/or other regulated environment work experience OR Associate's + 2 years Quality Assurance, manufacturing and/or other regulated environment work experience OR Bachelor's + 6 months Quality Assurance, manufacturing and/or other regulated environment work experience OR Master's
Job Responsibility
Job Responsibility
  • Quality oversight of new product introduction activities covering facilities, utilities, equipment, systems and process with alignment into the Amgen Quality Systems
  • Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations
  • Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls
  • Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA), change control records and validations
  • Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements
  • Oversee and provide guidance during on-the-floor analytical testing
  • Ensure that changes that could potentially impact product quality are assessed according to procedures
  • Ensure that deviations from established procedures are investigated and documented per procedures
  • Alert senior management of quality, compliance, supply and safety risks
  • Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation
What we offer
What we offer
  • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models where possible
  • Fulltime
Read More
Arrow Right

Sr. QA Associate I

The Sr. QA Associate I is a Quality Subject Matter Expert whom ensures manufactu...
Location
Location
United States , San Diego
Salary
Salary:
36.54 - 41.11 USD / Hour
pci.com Logo
PCI Pharma Services
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High school diploma or equivalent required
  • Bachelor’s degree preferred in a Life Sciences discipline or equivalent relevant experience required
  • Minimum of four to six (4-6) years of experience in documentation, QA, Manufacturing, technical quality, validation, or equivalent
  • Working knowledge of cGMP regulations 21CFR Part 11, 210, 211, 600 & EU guidelines and good documentation practices and data integrity
  • Knowledge of Fill Finish and Biologics production environments preferred
  • Familiarity working with electronic batch records
  • Detail oriented and strong interpersonal and verbal communication skills
Job Responsibility
Job Responsibility
  • Identify, investigate, resolve, and prevent compliance/deviance issues by real-time review of batch records and walk-through of the manufacturing areas
  • Independently reviews and approves production batch records and associated data for product release and determines if records are within range of cGMP regulations and good documentation practices
  • Independently performs quality operations within multiple manufacturing departments
  • Participates in multiple process improvement projects
  • Develop, revise, review and approve controlled documents including standard operating procedures (SOPs), Master Batch Records, analytical methods, protocols and tech transfer forms
  • Reviews and approves executed technical documentation in support of the manufacturing and testing of Drug Substance and Drug Product. Represents QA for high profile clients
  • Provides quality oversight of quality reports including deviations, corrective and preventive actions (CAPAs) and risk management plan (RMP)
  • Provides quality support to clients by attending meetings as needed, addressing quality issues that arise, and advising clients on compliant solutions
  • Supports the Facility/Equipment/Process Change Control System including developing recommendations for change tasks, managing timelines, and performing follow-ups to evaluate the effectiveness of changes
  • Ensures completeness and accuracy of information contained in all documents, document files, databases, and documentation systems
What we offer
What we offer
  • eligibility for an annual performance bonus
  • paid time off
  • health insurance coverage (including dental and vision)
  • a flexible spending account
  • a 401(k) plan
  • Fulltime
Read More
Arrow Right

Sr Associate Plant QA

If you feel like you’re part of something bigger, it’s because you are. At Amgen...
Location
Location
Netherlands , Breda
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in Life Sciences or related field or the equivalent combination of education and/or experience
  • Typically 3 years of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with experience in batch record review and investigations
  • Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and/ or Good Clinical Practice (GCP) knowledge with the ability to interpret and apply in mainly routine cases
  • Manufacturing and/or Quality analytical processes and operations
  • Fluent in the English language
Job Responsibility
Job Responsibility
  • Provide daily guidance and support to Production staff regarding compliance with Standard Operating Procedures and Work Instructions
  • Act as a first point of contact in case of production queries (quality related) during packaging and labeling operations
  • Review and approve batch production record data entries before production activities take place
  • Perform finished product checks during (commercial) production runs
  • Compile and review batch records for lots assembled, packaged, and labeled at ABR and contract manufacturers in preparation for disposition by QP
  • Review and approve Deviation records
What we offer
What we offer
  • Competitive salary
  • Bonus structure
  • Fixed 13th month
  • Holiday allowance
  • Collective health insurance
  • On-site gym
  • Vitality program
  • Restaurant with healthy food
  • Fulltime
Read More
Arrow Right
New

Sr Associate Supply Chain- Warehouse Technical Operations

In this vital role, you will be part of the Supply Chain team and report directl...
Location
Location
United States , New Albany
Salary
Salary:
83724.15 - 113273.85 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High school/GED + 4 years of supply chain, manufacturing, or warehouse technical operations experience
  • Associate’s + 2 years of supply chain, manufacturing, or warehouse technical operations experience
  • Bachelor’s + 6 months of supply chain, manufacturing, or warehouse technical operations experience
  • Master’s degree
Job Responsibility
Job Responsibility
  • Ensure the timely execution of warehouse operations in full compliance with GMP/GDP and EH&S requirements
  • Leverage strong knowledge of warehousing processes and with a drive for results
  • Deliver on the daily plan (outbound orders, inbound batches, process orders, cycle counts)
  • Ensure compliance with GMP/GDP and EHSS requirements
  • Own and/or provide input and support for quality system records (nonconformance, change control records, CAPA, SOPs) or other records (e.g. business continuity plan, user requirement specifications, risk assessments)
  • Assess impact of new requirements, changes, processes, regulations to the department
  • Act as warehouse representative in cross departmental projects
  • Act as a first point of contact for other departments (e.g. Production, Customer Service, QA, Planning)
  • Occasionally act as delegate for the Manager
  • Measure and report on Key Supply Chain Key Performance Indicators and drive continuous improvement leveraging Amgen standard tools and methods
What we offer
What we offer
  • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models where possible
  • Fulltime
Read More
Arrow Right
New

Sr Associate Software Engineer

Amgen is seeking a Sr. Associate Software Developer to contribute to the design,...
Location
Location
India , Hyderabad
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Master’s degree and 1 to 3 years of Computer Science, IT or related field experience OR Bachelor’s degree and 3 to 5 years of Computer Science, IT or related field experience OR Diploma and 7 to 9 years of Computer Science, IT or related field experience
  • Hands on experience with various cloud services, understand pros and cons of various cloud services in well architected cloud design principles
  • Hands on experience with Full Stack software development. Proficient in programming language Python(preferred), JavaScript,React.js/Node.js/Express.js SQL/NoSQL
  • Strong problem solving, analytical skills
  • Ability to learn quickly
  • Excellent communication and interpersonal skills
  • Experienced with API integration, serverless, microservices architecture.
Job Responsibility
Job Responsibility
  • End-to-End Ownership: Take ownership of complex software projects from conception to deployment, managing scope, risks, and timelines
  • Front-End Development: Design and implement responsive, accessible, and visually appealing user interfaces using HTML, CSS, JavaScript, and modern frameworks (React.js, Angular, or Vue.js)
  • Back-End Development: Build and optimize scalable server-side logic and APIs using Node.js, Express.js, or Python, ensuring secure integration with databases and microservices
  • Database Design & Management: Design, develop, and maintain SQL/NoSQL databases, focusing on security, performance, and reliability
  • API Development: Create RESTful or GraphQL APIs for communication between front-end, back-end, and external systems
  • Cross-Browser & Cross-Platform Compatibility: Ensure applications run seamlessly across multiple browsers, devices, and platforms
  • Generative AI & Innovation: Develop innovative solutions leveraging generative AI technologies to enhance applications and workflows
  • Cloud Deployment & Management: Deploy, manage, and scale applications on cloud platforms (AWS, Azure, GCP)
  • apply DevOps and CI/CD best practices
  • Software Architecture & Documentation: Design software architecture and produce technical documentation on system design, deployment, integration, disaster recovery, and operations
  • Fulltime
Read More
Arrow Right

Sr Associate IS Analyst

The Tester is responsible for executing testing and validation activities for cl...
Location
Location
India , Hyderabad
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 5–8 years of experience in testing, QA, or data validation roles
  • Strong experience in test case design, execution, defect lifecycle management, and test documentation
  • Experience with testing tools such as HP ALM, JIRA, and Confluence
  • Familiarity with functional, integration, and data validation testing approaches
  • Experience working in Agile/Scrum delivery models
  • Strong analytical, debugging, and problem-solving skills
  • Ability to work with cross-functional teams and deliver within sprint timelines
  • Strong SQL expertise for data validation, reconciliation, joins, aggregations, and exception analysis
  • Hands-on experience testing ETL/ELT pipelines (Databricks or similar) and validating data across relational databases
  • Experience working with AWS data services (S3 ingestion/storage) and SQL tools (DBeaver or similar)
Job Responsibility
Job Responsibility
  • Execute end-to-end testing (SIT, UAT, IQ, OQ, Dry Runs) including test design, execution, and defect management using VVM/Veeva Vault and ALM
  • Perform data validation across ETL/ELT pipelines, including SQL-based reconciliation, source-to-target validation, and verification of datasets, reports, and dashboards
  • Validate system functionality, data transformations, and integrations across GxP and Non-GxP systems based on business and regulatory requirements
  • Analyze and resolve data issues through defect triaging, production data validation, and ensuring data accuracy and integrity
  • Ensure completeness and correctness of testing artifacts, including test scripts, execution evidence, and defect documentation for audit/inspection readiness
  • Maintain end-to-end traceability (RTM) between requirements, test cases, execution results, and defects
  • Support validation lifecycle activities including impact assessment, risk-based testing approaches, and validation documentation updates
  • Support execution and closure of validation activities aligned with Change Requests (ServiceNow) ensuring proper documentation and approvals
  • Participate in release readiness activities including test summaries, defect reviews, and go/no-go decisions
  • Collaborate with Agile teams (BA, Dev, QA, Product) to deliver sprint testing outcomes and ensure timely, high-quality releases
  • Fulltime
Read More
Arrow Right

Sr Associate Software Engineer

Location
Location
India , Hyderabad
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree with 5 - 9 years of experience in Computer Science, IT or related field
  • Strong knowledge of information systems and network technologies
  • 5+ years of hands on experience developing SFMC applications
  • 5+ years of experience integrating Salesforce.com with other applications
  • Strong understanding of Agile, Scrum, Design Thinking, and Lean Startup principles
Job Responsibility
Job Responsibility
  • Take ownership of complex software projects from conception to deployment
  • Manage software delivery scope, risk, and timeline
  • Possesses strong rapid prototyping skills and can quickly translate concepts into working code
  • Contribute to both front-end and back-end development using cloud technology
  • Develop innovative solution using generative AI technologies
  • Conduct code reviews to ensure code quality and adherence to best practices
  • Create and maintain documentation on software architecture, design, deployment, disaster recovery, and operations
  • Identify and resolve technical challenges effectively
  • Stay updated with the latest trends and advancements
  • Work closely with product team, business team, and other stakeholders
  • Fulltime
Read More
Arrow Right

Sr Associate IS Bus Sys Analyst

We are seeking a Business Analyst – QA & Agile with 5+ years of experience to su...
Location
Location
India , Hyderabad
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 5+ years of experience in Business Analysis, QA/testing, or Agile roles
  • Strong experience in Agile/Scrum practices, including facilitating Scrum ceremonies
  • Experience in requirements gathering and documentation
  • Hands-on experience in software testing or data testing
  • Familiarity with web application testing and/or data platform testing
  • Working knowledge of data platforms (e.g., Databricks or similar — monitoring and basic troubleshooting) is a plus
  • Strong analytical, problem-solving, and communication skills
  • Ability to manage multiple responsibilities across BA, QA, and Scrum roles
  • Willingness to learn new tools, technologies, and take on additional responsibilities
Job Responsibility
Job Responsibility
  • Act as a Scrum Master or Agile facilitator for the team
  • Lead Agile ceremonies (daily stand-ups, sprint planning, retrospectives, backlog grooming)
  • Ensure adherence to Agile principles and best practices
  • Track sprint progress, identify risks, and remove blockers
  • Facilitate communication and coordination across cross-functional teams
  • Drive continuous improvement in team processes and delivery efficiency
  • Gather, analyze, and document business and functional requirements
  • Translate business needs into clear user stories and acceptance criteria
  • Work closely with stakeholders to ensure alignment between business expectations and technical delivery
  • Support backlog refinement and prioritization activities
  • Fulltime
Read More
Arrow Right