QC Associate / Specialist (EM)

Role Summary

QC Associate / Specialist (EM) responsible for GMP-compliant environmental monitoring of cleanrooms, performing growth promotion, maintaining SOPs, calibrating equipment, managing inventory, and tracking QC data in support of cell therapy manufacturing.

Responsibilities

• Execute GMP-compliant environmental monitoring of cleanrooms by performing non-viable and viable particulate sampling on a routine basis.
• Perform growth promotion to qualify media.
• Contribute to reviewing SOPs, forms, and logbooks related to environmental monitoring and microbiological methods.
• Governing the upkeep, calibration, and preventive maintenance of lab equipment and instruments.
• Manage inventory of environmental monitoring samples, lab supplies and materials.
• Support tracking and trending of QC data.

Qualifications

• BS or MS in biological sciences or a related field.
• 2+ years of pharmaceutical or biotechnology industry experience, including experience in cell therapy or microbiology. Candidates at the specialist level will require more experience.
• Previous experience performing environmental monitoring in a cleanroom.
• Excellent written and oral communication skills.