QC Microbiology Analyst

Actalent - Allendale, NJ

Full-time - Entry Level

Allendale, NJ

10,001+ employees

Administrative and Support Services

About the position

The QC Microbiology Analyst position at Actalent involves performing microbiology testing methods within an ISO-5 regulated cleanroom environment. The role focuses on environmental monitoring, endotoxin testing, and ensuring compliance with FDA and EU regulatory standards. This position is critical for maintaining quality control in a growing CDMO cell and gene therapy company.

Responsibilities

• Perform various microbiology testing methods including viable and non-viable air sampling, surface plating, endotoxin testing, and bioburden testing.
• Participate in aseptic process qualifications, such as aseptic gowning and media fill reads.
• Conduct Bacterial Endotoxin and Sterility Testing.
• Perform growth promotion testing of microbiological media.
• Conduct routine Environmental Monitoring.
• Perform water testing including TOC, conductivity, and Bioburdens.
• Utilize microbial isolation techniques and perform Gram stain identifications.
• Send out samples to contract labs and track results/reports.
• Evaluate environmental/personnel monitoring samples and create NOEs for action levels.

Requirements

• Bachelor's degree in Microbiology or a relevant field.
• Minimum of 6-12 months of experience with environmental monitoring or within the biopharmaceutical industry or equivalent.
• Strong knowledge of FDA and EU regulatory standards.
• cGMP experience required.
• Strong knowledge of microbiological test methods and philosophies.
• Strong knowledge of quality systems and ability to interpret Quality standards of implementation and review.
• Proficient with computer software including MS Office and LIMS (MODA experience preferred).