Quality Control - QC Microbiology Analyst II

Minaris Advanced Therapies•Allendale, NJ

1d•Onsite

About The Position

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. Position Summary 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. Essential Functions and Responsibilities 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.

Requirements

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.
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
The QC Microbiology Analyst II must be able to maintain aseptic behavior within a cleanroom environment for an extended period (4-5 hours).
Occasionally personal protective equipment may be required including lab coat, latex gloves, safety glasses and/or respirator
The employee is frequently required to lift, move, or carry up to 25 pounds.
This role is occasionally sedentary. Sedentary entails sitting most of the time but may involve walking or standing for brief periods.
Gowning proficiency as needed.
Heavy cryo-gloves must be used when working with liquid nitrogen
Must be capable of moving, sitting, stretching, stooping, reaching with hands and arms, and have vision sufficient to read materials.
Must be capable of using hands and fingers to operate a computer and other office productivity machinery such as copy machine, printer, and calculator.
Must have the ability to communicate information and ideas so others will understand. Must be able to exchange accurate information in person, and on the telephone.
Must have the ability to work in a team-oriented environment and with clients
Must be able to work during the weekend, holidays and as required by the company
While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens
Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen
Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.
Must be able to handle the standard/moderate noise of the manufacturing facility

Nice To Haves

Experience in Environmental monitoring or within the biopharmaceutical industry experience preferred.

Responsibilities

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.
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.