Frederick, MD, 21705, USA
2 days ago
Quality Control Microbiologist EM
Job Title: Quality Control Microbiologist - Environmental MonitoringJob Description Join our dynamic team as a QC Microbiologist at our cutting-edge commercial cell therapy production center in Frederick, MD. You will collaborate with the Quality Control team to support pioneering cancer immunotherapy efforts. This role involves performing microbiological testing for commercially manufactured products, focusing on product testing, utility testing, and environmental monitoring. Responsibilities + Perform environmental and utility monitoring and sampling as a primary function. + Conduct routine and non-routine inspection of media fill samples, collection, and testing of media, final products, validation-related, and critical utility samples according to SOPs. + Receive, quarantine, and store purchased microbiological media pending laboratory release. + Monitor biohazardous waste and coordinate its removal with qualified safety personnel. + Participate in validation and commercial/developmental manufacturing activities. + Review and issue Environmental Notifications based on raw data and validated electronic data acquisition systems. + Represent QC for area of specialization in site meetings. + Support testing of solid oral dosage, packaging component testing, raw material, and sterile product testing. + Troubleshoot standard instrumentation and test methods. + Perform activities in support of final product release testing, including endotoxin, sterility, and particle isolation tests. + Conduct raw material testing, such as media growth promotion where required. + Perform activities in support of environmental monitoring, including surface viable air, non-viable air, and personnel monitoring. + Perform activities in support of bioburden testing of water and product, viable/non-viable particles, and moisture testing of compressed gases/air. Essential Skills + Quality control in microbiology + Environmental monitoring + Investigation and root cause analysis + Good Manufacturing Practices (GMP) + Aseptic techniques and cleanroom protocols + Air and water sampling + Proficiency in Microsoft Office applications + Strong verbal, written, and interpersonal communication skills Additional Skills & Qualifications + 2+ years of relevant experience and a High School diploma OR BS degree in a related field + Prior experience in the biopharmaceutical or pharmaceutical industry + Basic knowledge of current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs) + Basic knowledge of general microbiology techniques such as gram staining, aseptic technique, and plate streaking technique + Knowledge of USP and other regulatory requirements + Familiarity with HPLC and UPLC systems + Ability to work effectively in a team environment + MODAL/LIMS proficiency + Technical training on environmental monitoring of facility and utility systems Work Environment The position is based in a GMP Manufacturing Suite requiring gowning, with office duties related to environmental monitoring. The team is part of a small biotech company working on groundbreaking mRNA technology targeting underserved diseases, offering a unique opportunity to work in a less competitive market. Pay and Benefits The pay range for this position is $30.00 - $36.00/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 • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Frederick,MD. Application Deadline This position is anticipated to close on Aug 16, 2025. 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 due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
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