QC Scientist, Microbiology: Bioburden & BET Expert

GSK; Upper Merion Township (Montgomery County); On-site; USD 90,000 - 115,000; Full time

Job summary

GSK US is seeking a QC Scientist – Microbiology to perform and support microbiological testing of raw materials, in-process materials, drug substances, drug products, and environmental samples in a GMP setting, with roughly 80% hands-on work.

The role emphasizes Bioburden and Bacterial Endotoxin Testing, requires open availability with weekend work, and offers opportunities to lead key lab activities and collaborate across Quality, Manufacturing and Technical Operations.

Qualifications

• Bachelor’s degree in microbiology, biology, biotechnology or related life science with 3+ years of hands‑on microbiology laboratory experience
• OR an associate degree in a scientific discipline with 5+ years of hands‑on microbiology laboratory experience
• OR a master’s degree in microbiology, biology, or a related life science discipline with a minimum of 1 year of hands‑on microbiology experience in a GMP‑regulated environment.
• Experience working in a GMP/GxP‑regulated pharmaceutical, biotechnology, medical device, or healthcare environment.
• Experience performing Bioburden and Bacterial Endotoxin Testing (BET).

Responsibilities

• Perform routine and non-routine microbiological testing of materials and samples (raw materials, in-process, drug substance, drug product, EM/UM).
• Execute Bioburden Testing and Bacterial Endotoxin Testing (BET) per approved procedures and compendial requirements.
• Support testing to enable product release, stability studies, validation activities, and manufacturing operations.
• Collect, test, review, and trend utility monitoring samples from water, clean steam, and gas systems.
• Escalate quality or compliance concerns promptly to management.
• Accurately document laboratory activities and results per cGMP, GDP, and ALCOA+ data integrity principles.
• Identify opportunities for process improvements and lab efficiencies.
• Perform routine lab housekeeping and inventory management.
• Support method qualifications, method transfers, equipment qualifications, and validation activities.
• Perform other duties as assigned.

Skills

Data Integrity

Detail-Oriented

Digital Fluency

GxP Regulations

Lean Management

Problem Solving

Quality Assurance

Quality Control

Risk Awareness

Testing Operations

Education

Bachelor's degree in microbiology / biology / biotechnology or related life science

Associate degree in scientific discipline with 5+ years microbiology experience

Master's degree in microbiology / biology or related Life Science with 1+ year GMP experience

Tools

SAP/ERP

LE S/LES-EM

LIMS

WebStatistica

ELN (Electronic Lab Notebook)

Veeva

Job description

GSK US is seeking a QC Scientist – Microbiology to perform and support microbiological testing of raw materials, in-process materials, drug substances, drug products, and environmental samples in a GMP setting, with roughly 80% hands-on work.

The role emphasizes Bioburden and Bacterial Endotoxin Testing, requires open availability with weekend work, and offers opportunities to lead key lab activities and collaborate across Quality, Manufacturing and Technical Operations.