QC Analyst, Microbiology/Environmental Monitoring (EM)

Raleigh, USA

Published on September 20, 2021

The QC Analyst, Microbiology/Environmental Monitoring will be responsible for supporting and ensuring GMP manufacturing operations at Cellectis’ GMP manufacturing facility in Raleigh NC.. The incumbent will support the development, qualification and requalification of the isolator decontamination cycles. The Microbiology/ EM analyst will also perform daily Microbiology laboratory activities and documentation including, but not limited to rapid sterility (BacT/Alert) testing, kinetic endotoxin testing and environmental monitoringThe QC Analyst will support investigations for OOS and other non-conforming results. The analyst will also author and review procedures, protocols, and reports.

Responsibilities

  • Perform/ support requalification of isolator decontamination cycles
  • Routinely perform microbiological analyses such as growth promotion, gram stain, kinetic endotoxin and rapid sterility testing. Perform environmental monitoring of GMP manufacturing rooms, isolators and utilities
  • Support investigations to determine root cause of OOS and other non-conforming results and implement appropriate corrective and preventative actions.
  • Maintain supply of lab materials, reagents, and consumables
  • Author and train on SOPs, protocols and technical reports.
  • Liaise with other departments including Quality Assurance, Manufacturing and Facilities to address compliance issues and to implement corrective actions and to improve programs.
  • Travel up to 5% of the time (if required)
  • Such other responsibilities and duties as the Company may from time to time assign.

Requirements

  • Bachelor's degree with 1-5 years of hands-on experience in microbiology laboratory and qualification of Isolators cycles.
  • Knowledge and technical expertise related to Isolator H202 decontamination and biological indicators.
  • Strong written and verbal communication skills.
  • Understanding of aseptic microbiological techniques.
  • Ability to work independently, open to seeking guidance and a self-starter.
  • Ability to manage multiple projects simultaneously.
  • Understanding of cGMP compliance and aseptic manufacturing operations.
  • Close attention to detail.
  • Understanding of QC Environmental Monitoring, and Microbiological techniques.

Physical Requirements

Requires the ability to sit or stand at a computer for long stretches of time and type. Frequently operates a computer and other office productivity machinery, such as a calculator, copy machine, and computer printer. The person in this position needs to occasionally move about inside the office to access file cabinets and office equipment. Frequently walks around the laboratory, manufacturing, warehouse, and office areas to perform their job functions. Safely works with hazardous and biohazardous materials using appropriate personal protective equipment (PPE). Requires the ability to follow proper gowning procedures and work in cleanrooms for uninterrupted periods of time of at least 4 hours. May lift objects up to thirty pounds.