QC Microbiology Analyst
21 hours ago
Allendale
Job DescriptionJob Title: QC Microbiology Analyst Job Description The QC Microbiology Analyst performs environmental monitoring and microbiological testing in a cleanroom and Good Manufacturing Practice (GMP) environment to support advanced cell therapy and biotechnology manufacturing. This role focuses on aseptic techniques, environmental and personnel monitoring, and accurate documentation of results using specialized databases. The position offers extensive training in environmental monitoring and the opportunity to contribute to a rapidly growing organization in the CAR-T and cell therapy industry. Responsibilities • Perform routine environmental monitoring in cleanroom and GMP areas, including active air, passive air, and surface viable testing., • Conduct micro sampling, personnel monitoring, and surface plating to assess contamination levels in classified areas., • Monitor and document equipment conditions as part of the environmental monitoring program., • Analyze and read microbiological plates after incubation, accurately interpreting results and documenting findings., • Collect and process air and water samples using aseptic techniques to ensure compliance with environmental and quality standards., • Perform bioburden testing and other microbiological assays as required to support quality control activities., • Use and maintain the MODA database or similar systems to document environmental monitoring data and test results in a timely and accurate manner., • Follow standard operating procedures (SOPs) for all microbiological and environmental monitoring activities, ensuring adherence to GMP and ISO standards., • Perform aseptic technique consistently, including proper pipetting, plating, swabbing, and handling of microorganisms., • Prepare, incubate, and subculture microbiological samples, including performing cell counts and gram stains as needed., • Support equipment monitoring activities by documenting environmental conditions and reporting deviations or abnormal results., • Participate in extensive environmental monitoring training and apply learned techniques to daily operations., • Complete gowning qualification and maintain proper gowning practices to work effectively in cleanroom and aseptic environments., • Contribute to maintaining a clean and controlled environment by performing cleaning tasks related to microbiological and environmental monitoring activities., • Collaborate with cross-functional teams in quality control and manufacturing to ensure accurate communication of environmental monitoring results., • Adhere to all safety, quality, and regulatory requirements while working with microorganisms and within cleanroom facilities.Essential Skills, • At least 1 year of environmental monitoring experience in a cleanroom or GMP environment., • 1–3 years of experience with sampling, personnel monitoring, and surface plating., • Demonstrated experience working within an aseptic environment and applying aseptic techniques., • Basic microbiology knowledge, including microbiology techniques and working with microorganisms., • Hands-on experience with environmental monitoring, including air and water sampling and surface monitoring., • Proficiency in aseptic technique, pipetting, surface plating, and swabbing., • Familiarity with cleanroom operations and ISO standards related to environmental monitoring and microbiology., • Ability to follow SOPs and quality control procedures in a regulated environment., • Experience with cell culture, cell counts, and related microbiological assays., • Competence in incubation, subculturing, plating, and gram staining., • Ability to read, interpret, and document microbiological test results accurately., • Bachelor’s degree in a related scientific field (such as Microbiology, Biology, or a similar discipline)., • Gowning certification or the ability to obtain gowning qualification for cleanroom work., • Strong attention to detail and adherence to quality and compliance standards.Additional Skills & Qualifications, • Experience using MODA or similar databases for documenting environmental monitoring and microbiology data., • Knowledge of bioburden testing and quality control practices in pharmaceutical or biotechnology settings., • Familiarity with CAR-T, cell therapy, or related biotechnology manufacturing environments., • Understanding of environmental monitoring program design and execution in GMP facilities., • Experience working under SOPs and quality systems aligned with ISO and regulatory expectations., • Ability to work independently and as part of a team in a fast-paced, growth-oriented environment., • Strong organizational skills and the ability to manage multiple monitoring and testing tasks., • Willingness to participate in extensive environmental monitoring training and ongoing skill development.Work Environment This role is based in a cleanroom aseptic environment within a GMP-regulated facility, focused on supporting advanced biotechnology and cell therapy operations. The QC Microbiology Analyst will work primarily on 2nd shift, with available schedules including Sunday to Wednesday from approximately 3:30 pm to 2:00 am and Wednesday to Saturday from approximately 3:30 pm to 2:00 am, depending on assignment. Initial training will take place on first shift, Monday through Friday from 8:00 am to 4:30 pm, for an estimated duration of 4–6 weeks. The position involves continuous work in controlled cleanroom areas, including gowning and maintaining strict aseptic and cleanliness standards. The environment requires consistent use of microbiology equipment, incubators, and monitoring devices, as well as regular use of databases such as MODA for documentation. Team members follow defined SOPs, quality procedures, and safety guidelines while working with microorganisms and performing environmental monitoring. The organization is expanding its operations, offering opportunities to grow within a fast-paced, innovative biotechnology setting focused on CAR-T and cell therapy. Job Type & Location This is a Contract to Hire position based out of Allendale, NJ. Pay and Benefits The pay range for this position is $30.00 - $30.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision, • Critical Illness, Accident, and Hospital, • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available, • Life Insurance (Voluntary Life & AD&D for the employee and dependents), • Short and long-term disability, • Health Spending Account (HSA), • Transportation benefits, • Employee Assistance Program About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.