Microbiology Scientist

Role Summary

The Microbiologist Scientist will test drug products and drug substance samples for release. Sample and test raw materials for production use, as well as sample and test water and environmental monitoring samples. Location: King of Prussia, PA, USA.

Responsibilities

• Perform and may train others on routine and non routine testing of laboratory samples (raw materials, drug product, drug substance, in-process, water, validation, etc) utilizing various microbiological techniques and assays including Environmental Monitoring, Bioburden, and Endotoxin.
• Perform utility sampling (water, clean steam, gases, vialble air, non viable air and surface monitoring)
• Review and revise SOPs
• Initiate and Participate in laboratory investigations.
• May support change controls and CAPAs
• Basic understanding of cGXP, and data integrity guidelines
• Assist with the execution of validation protocols and reports.
• Routinely utilize SAP/MERPs, LES, and LES EM for data entry.
• Performs routine departmental GMP activities (preventive maintenance, audits, work orders, etc)
• Laboratory upkeep and maintenance (5S, routine equipment/glassware cleaning, autoclave, etc)

Qualifications

• Required: 1+ years of experience in a GMP/GxP regulated laboratory environment
• Preferred: Good communication skills
• Preferred: Works well in a team environment as well as ability to work independently.
• Preferred: Make sound compliant decisions when needed.
• Preferred: Experience with Excel, Word and PowerPoint
• Preferred: Basic understanding of cGXP, and data integrity guidelines
• Preferred: Role requires weekend and off-shift coverage

Education

• Bachelor’s degree in a scientific discipline