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Environmental Monitoring Analyst I

2 months ago

Columbus, Ohio, United States Forge Biologics Full time
About Forge Biologics

Forge Biologics is committed to transforming the landscape of gene therapies, focusing on patient-centric solutions. Our state-of-the-art facility is dedicated to the production of AAV vectors, playing a crucial role in the advancement of innovative therapies.

Team Overview

The Quality Control - Environmental Monitoring/Microbiology team at Forge is integral to maintaining the integrity and safety of our gene therapy products. This department specializes in microbiological assessments and environmental surveillance to prevent contamination and ensure compliance with industry regulations.

Position Summary

As a Quality Control Analyst I specializing in Environmental Monitoring and Microbiology, your role will involve performing essential microbiological evaluations, executing environmental monitoring protocols, and enhancing manufacturing processes within our GMP-compliant facility. You will contribute to the production of transformative gene therapies.

Key Responsibilities
  • Execute microbiological evaluations, including Gram staining, Endotoxin testing, and bioburden assessments.
  • Implement environmental monitoring protocols to guarantee adherence to regulatory standards.
  • Interpret Environmental Monitoring data trends and participate in necessary corrective actions.
  • Formulate work plans to align with production goals and collaborate on process validation initiatives.
Qualifications
  • Bachelor's Degree in Microbiology or a related discipline.
  • Demonstrated technical proficiency and analytical problem-solving abilities.
  • Strong organizational and communication skills.
  • Capacity to thrive in a dynamic environment and adjust to evolving priorities.
  • Preferred: Experience in a GxP setting and familiarity with microbiological assessments.
Work Environment

This position requires engagement in both laboratory and office settings, with physical demands tailored to specific tasks. Personal Protective Equipment (PPE) is mandatory, and the ability to operate in confined spaces is essential.

Diversity and Inclusion

Forge Biologics champions equal opportunity and is dedicated to fostering a diverse and inclusive workforce. We strive to create a supportive environment for all team members.

Company Culture

Become part of a dedicated team focused on the manufacturing of gene therapies and the realization of our mission. Our core values—Hardworking, Open, Purpose-Driven, and Engaged—are the foundation of our organizational culture.