Quality Control - QC Microbiology Analyst II

Minaris Advanced Therapies; Allendale (NJ); On-site; USD 55,000 - 70,000; Full time

Benefits offered by this job

Comprehensive medical benefits

401(k) plan

Tuition assistance

Paid time off

Job summary

A biotechnology company in Allendale, NJ is seeking a Quality Control Microbiology Analyst II to support clinical and commercial production. The role involves environmental monitoring activities, data review, and ensuring compliance with quality standards. Candidates should have a BA/BS in a science-related field and at least 2 years of relevant experience, along with strong communication and technical writing skills. This position requires a detail-oriented individual ready to work in a fast-paced manufacturing environment.

Qualifications

• Knowledge of quality standards for implementation and review.
• Experience in Environmental monitoring or within the biopharmaceutical industry preferred.
• Must be flexible with Production schedule.

Responsibilities

• Conduct environmental monitoring in controlled rooms.
• Review Environmental Monitoring data and perform EM trending.
• Initiate quality events in Veeva and manage events with outside departments.

Skills

Knowledge of quality systems

Strong written and oral communication skills

Technical writing skills

Detail-oriented

Ability to multi-task

Flexibility to adapt

Education

BA/BS in a science or relevant field

Minimum 2 years of experience in relevant fields

Tools

Microsoft Office

MODA/LIMS

Job description

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.

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.

• 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, Skill & Ability

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

Education & Experience

• 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

Quality Requirements

• 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.

Working Environment

Onsite Employee: Employee will work with moderate noise level. Employee will perform tasks while experiencing numerous interruptions. The work environment is fast paced. This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions and conduct. Off-shift, weekend and overtime duties may be required. While performing the job duties of this job, the employee is regularly required to use English written and oral communication skills.

• Must be able to work during the weekend, holidays and as required by the company
• Must be able to handle the standard/moderate noise of the manufacturing facility
• The work environment requires gowning, hair net, safety glasses, gloves, and foot coverings.
• This role operates within a professional office environment of a manufacturing operations plant. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines. Seating is mixed and includes open space seating, cubicle, and office space.
• 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, proper PPE must be worn.
• Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.
• Other exposures may include gases (nitrogen), or corrosive sanitizing chemicals (Clorox, Hydrogen peroxide), or exposure to liquid nitrogen.

Physical Requirements

The physical demands described here represent those that must be met by an employee to perform the essential functions of the job successfully.

• 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.

Special Working Conditions

• 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.
• Other exposures may include gases (nitrogen), or corrosive sanitizing chemicals (Clorox, hydrogen peroxide), or exposure to liquid nitrogen.
• Must be able to handle the standard/moderate noise of the manufacturing facility
• This role operates within a professional office environment of a manufacturing operations plant. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines. Seating is mixed and includes open space seating, cubicle, and office space.

Disclaimer

The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. Duties, responsibilities, and activities may change at any time with or without notice.

The estimated base salary range for each open position based in the United States of America is included for all our current openings. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) as part of the compensation package. Minaris Advanced Therapies employees are eligible for a comprehensive benefits package, including medical insurance, vision insurance, dental insurance, 401(k), paid time off, tuition assistance, and more.