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Associate Quality Assurance

2-4 years
Not Disclosed
10 June 19, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Job Title: Associate Quality Assurance

Job Summary

Amgen Singapore Manufacturing is hiring an Associate Quality Assurance professional to support its Lot Disposition group, ensuring the highest quality raw materials for its cutting-edge biotech therapies. This on-site role involves raw material inspection, sampling, rapid ID testing, and maintaining GMP standards for Amgen’s global supply chain, playing a vital role in the delivery of safe and effective medicines.


Key Responsibilities

  • Comply with safety protocols, cGMP standards, and regulatory requirements.

  • Perform raw material inspection, sampling, and rapid ID testing per SOPs and methods.

  • Generate accurate documentation (electronic/handwritten) per regulatory guidelines.

  • Review records to ensure raw materials meet specifications.

  • Manage dashboards, inventory, housekeeping, and provide audit support.

  • Support site-wide continual improvement projects.

  • Identify and communicate quality, compliance, and safety risks.

  • Participate in deviation handling and problem resolution.

  • Execute additional duties as required by management.


Required Skills & Qualifications

  • Bachelor’s degree with 2 years of relevant experience; OR

  • Associate’s degree with 4 years; OR

  • High School Diploma/GED with 6 years in a regulated environment.

  • Hands-on experience with laboratory and process equipment troubleshooting.

  • Familiarity with LIMS, SAP, and TrackWise systems.

  • Strong understanding of GMP and regulatory standards.

  • Ability to interpret and evaluate basic chemistry data.

  • Skilled in documentation review and data evaluation.

  • Proficiency in MS Office and Computer-Based Training systems.

  • Excellent organizational, problem-solving, and communication skills.

  • Ability to work in shifts, including nights and weekends if required.

  • Must pass vision and depth perception medical qualifications essential for visual inspections.


Perks & Benefits

  • Comprehensive Total Rewards Plan covering health, finance, career development, and work-life balance.

  • Opportunity to work in a diverse, inclusive, and globally recognized biotech environment.

  • Access to training and career advancement across Amgen’s global network.


Company Description

Amgen is a world-leading biotechnology company pioneering innovative therapies to treat serious diseases. With a commitment to quality and scientific excellence, Amgen’s Singapore Manufacturing site plays a crucial role in delivering life-saving medicines globally.


Work Mode

On-site (Singapore)


Salary/Compensation

Not disclosed in the job description.


Call to Action

Ready to shape the future of biotech manufacturing? Apply now to become an integral part of Amgen’s Quality Assurance team and help ensure the delivery of life-changing medicines to patients worldwide.