Quality Assurance Specialist

17 hours ago

Singapore ESCO ASTER PTE. LTD. Full time
Quality Control Specialist

Esco Aster Pte Ltd, a leading contract development and manufacturing organization, is seeking a highly skilled Quality Control Specialist to join our team. As a Quality Control Specialist, you will play a critical role in ensuring the quality and safety of our products.

Key Responsibilities:
  • Establish and maintain quality control procedures, including drafting and reviewing SOPs.
  • Responsible for environmental monitoring, including viable and non-viable monitoring of cleanrooms, water, and gases.
  • Perform microbiological testing of water, raw materials, in-process, finished products, stability, validation, and utility samples.
  • Support sample management functions and ensure timely inventory of testing support media and consumables.
  • Write, review, and update SOPs to operate EM and Microbiology operations in compliance with current GMP requirements.
  • Maintain data integrity and appropriate traceability.
  • Identify and participate in Root Cause Analysis (RCA) and recommend corrective and preventive actions.
  • General lab support, including housekeeping, equipment maintenance, and inventory management.
Requirements:
  • Degree with at least 3 years or Diploma with at least 5 years of experience in QC (Microbiology and Environmental Monitoring) from a highly regulated cGMP manufacturing environment.
  • Ability to prioritize work and multitask.
  • Knowledge and experience on QC laboratory operations and procedures, analytical test methods, troubleshooting, and evaluation of analytical results.
  • Thorough knowledge and understanding of current regulatory requirements of cGMP manufacturing.
  • Good knowledge and understanding of Biologics manufacturing, aseptic operations, and cleanroom behavior.

As a Quality Control Specialist at Esco Aster Pte Ltd, you will have the opportunity to work in a dynamic and fast-paced environment, collaborating with cross-functional teams to ensure the highest quality products. If you are a motivated and detail-oriented individual with a passion for quality control, we encourage you to apply for this exciting opportunity.

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