Quality Control - QC Microbiology Analyst II

Overview

Be part of something bigger at Minaris Advanced Therapies—where every role contributes to creating hope for patients around the world. As a global leader in cell and gene therapy development, manufacturing, and testing, we turn breakthrough science into real-world treatments that change lives. Our team of over 1,000 experts across North America, Europe, and Asia has helped bring transformative therapies to market.

At Minaris, you’ll join a purpose-driven community focused on innovation, collaboration, and patient impact. Whether you’re in the lab, in the cleanroom, or behind the scenes, your work will directly support life-saving therapies and make a lasting difference. If you re passionate about advancing cutting-edge science and believe in the potential of cell and gene therapies, we invite you to help shape the future of medicine—one patient at a time.

The Quality Control Microbiology Analyst II serves as a support role to clinical and/or commercial production. The QC Microbiology Analyst will perform environmental monitoring activities including, but not limited to, non-viable particulate testing, active air viable, passive air viable, surface viable, and personnel monitoring. The work schedule for this role is Wednesday - Saturday from 6:30am - 5:00pm.

Below is the summary of the role responsibilities. This is not an exhaustive list of all responsibilities, duties, skills, efforts, requirements or working conditions associated with the role. While this is intended to be an accurate reflection of the current job, management reserves the right to revise the job or to require that other or different tasks be performed as assigned with or without notice.

• Environmental monitoring in controlled rooms: perform Non-viable and viable monitoring, Active viable air, Personnel monitoring, Surface sampling, Passive air monitoring, Equipment EM monitoring. Perform plate reads and incubations
• Environmental Monitoring data review and EM trending
• Ensure equipment is properly maintained/calibrated and monitored in Vaisala system
• Initiate quality events in Veeva and triage events with outside departments
• Assist with routine laboratory testing
• Inventory Management of lab materials and instruments
• Shipping of test samples and equipment to contract laboratories for testing
• Maintain laboratory audit readiness/Good Laboratory housekeeping practices
• Any additional request, per management needs
• Complete all documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)
• Regular and reliable attendance on a full-time basis.
• Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
• Embodies Minaris Advanced Therapies values and aligns daily actions with department and company culture.

Knowledge of quality systems and ability to interpret Quality standards for implementation and review.

Strong written and oral communication skills

Technical writing skills

Technical training experience

Must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities

• BA/BS in a science or relevant field required or equivalent experience
• Minimum 2 years of experience or equivalent experience.
• Experience in Environmental monitoring or within the biopharmaceutical industry experience preferred.
• Proficient with computer software such as Microsoft Office, MODA/LIMS
• Must be flexible with Production schedule which may require coming in early or working later

• Ensure compliance with all FDA and Worldwide Quality & Compliance regulations in all aspects of your work.
• Adhere to established procedures and protocols, prioritize continuous training and skill development, and uphold the highest standards of data integrity to ensure accuracy, compliance, and operational excellence.

Onsite…