Department: Quality Control

Reports To: QC Microbiology Manager

Position Type: Full-time

Travel Requirements: Approximately 10%

Job Summary:

We are currently seeking a highly skilled and motivated QC Microbiology Specialist to join our Quality Control team. The ideal candidate will support GMP manufacturing by performing microbiological testing and environmental monitoring to ensure the timely release of materials, intermediates, and finished products in compliance with FDA/EU regulations and BeiGene procedures. This role requires a detailed-oriented individual with a strong background in microbiology and a commitment to maintaining high-quality standards.

Essential Functions:

• Perform QC Microbiology laboratory testing, including bioburden, endotoxin, sterility, and microbial ID testing.
• Support routine QC operations such as instrument qualification and maintenance, SOP generation and revision, and inventory management.
• Conduct laboratory investigations (OOS, Out of Trend, deviations, invalid assays) and implement CAPAs.
• Participate in facility qualification activities and environmental monitoring of cleanroom suites.
• Engage in method transfer and validation activities, including protocol preparation and execution.
• Manage reagents and supplies inventory for the laboratory.
• Ensure compliance with USP/EP and cGMP/EU GMP regulations.

Requirements:

• Bachelor's Degree in Microbiology, Biology, or a related scientific discipline.
• 2+ years of experience in an FDA-regulated biotechnology or pharmaceutical company; 5+ years preferred with no higher education.
• Proficiency in microbiological testing methods (endotoxin, bioburden, sterility testing, microbial identification, PCR, etc.).
• Familiarity with USP/EP standards and cGMP/EU GMP regulations.
• Strong analytical, problem-solving, and communication skills.
• Excellent time management and prioritization abilities.
• A hands-on, can-do attitude with meticulous attention to detail.
• Self-motivated with a strong commitment to learning and development.

Computer Skills:

• Proficiency in MS Office (Outlook, Word, Excel, PowerPoint).

Physical & Travel Requirements:

• Ability to gown into cleanrooms and stand/move for extended periods.
• Willingness to travel approximately 10%.