QC Microbiology Analyst I

Job Description Allendale, 75 Commerce Drive, Allendale, New Jersey, United States of America 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 I 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. Essential Functions and Responsibilities Below is the summary of the role 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 and good laboratory housekeeping practices Any additional request, per management needs Complete all documentation according to written standard operating procedures in accordance with 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 reflect 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 0–2 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 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. Physical Requirements The physical and mental demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties the employee is: Frequently required to sit, and to reach to use computers and other office equipment Constantly stand for extended periods of time, up to four hours/time Frequently required to lift up to 30 pounds Constantly required to view objects at close and distant ranges with hand and eye coordination Constantly required to communicate with others Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the work day; frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time. 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 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 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 Gowning proficiency as needed Heavy cryo‑gloves must be used when working with liquid nitrogen 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. 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. #J-18808-Ljbffr Minaris Advanced Therapies