Urgently hiring an Quality Control Analyst for a growing CDMO cell and gene therapy company!

Position Summary:

The QC Environmental Monitoring Analyst will be responsible for performing various different microbiology testing methods including viable and non-viable air sampling, surface plating, endotoxin testing, bioburden testing and gowning within an ISO-5 regulated cleanroom.

Job Description:

• Participate in aseptic process qualifications, such as aseptic gowning and media fill reads.
• Perform Bacterial Endotoxin and Sterility Testing.
• Perform growth promotion testing of microbiological media.
• Perform Environmental Monitoring on a routine basis.
• Perform water testing including TOC, conductivity, and Bioburdens
• Perform 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.

Qualifications:

• Bachelor’s degree in a Microbiology or 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 with MS Office and LIMS (MODA experience preferred).