Microbiological Testing Specialist

24 hours ago

Singapore beBeeMicrobiologist Full time

The role of a Microbiological Testing Specialist is to conduct microbiological testing and support laboratory operations for drug substance release in a GMP-regulated environment.

This position requires the ability to perform various types of microbiological testing, including environmental monitoring, bioburden, endotoxin, and sterility testing. The specialist will also be responsible for managing sample storage, documentation, and data entry to ensure compliance with regulations.

Key Responsibilities:

  • Perform Microbiological Testing: Conduct microbiological testing on various sample types, including API, drug substances/products, and stability samples.
  • Manage Sample Storage: Ensure proper storage of samples, maintain accurate records, and manage inventory levels.
  • Support Laboratory Operations: Assist in day-to-day QC operations, including logbook checks, reagent preparation, and equipment usage.
  • Ensure Timely Completion: Meet release and stability timelines by completing testing efficiently and accurately.
  • Participate in Inspections: Participate in inspections, internal audits, and prepare related documentation to ensure compliance.
  • Support Test Method Optimization: Contribute to test method optimization and process improvements for lab efficiency and compliance.
  • Maintain Training and Knowledge: Complete required training for new methods, equipment, and safety procedures.

Requirements:

  • Education: Min Degree or equivalent qualification in Microbiology, Biotechnology, or related scientific field.
  • Experience: 2 to 5 years of hands-on experience in a GMP pharmaceutical QC microbiology lab.
  • Skill Set: Skilled in microbiological testing techniques, solid understanding of GxP compliance, lab safety, and data integrity standards.
  • Familiarity: Familiar with aseptic technique and sample management processes.
  • Additional Skills: Strong attention to detail, accuracy in documentation, and continuous improvement mindset.
  • Interpersonal Skills: Able to work independently and collaboratively in a fast-paced lab environment.

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