Quality Control Microbiologist EM

Quality Control Microbiologist

Join our new commercial cell therapy production center in Frederick, MD as a Quality Control Microbiologist. You will collaborate with the Quality Control team to support our efforts in cancer immunotherapy. This role involves microbiological testing for commercially manufactured products, including 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 Quality Control in site meetings for areas of specialization.
• 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, such as tests for endotoxin, sterility, and particle isolation, and raw material testing, such as media growth promotion.
• Support environmental monitoring, including surface viable air, non-viable air, and personnel monitoring.
• Conduct bioburden testing of water and products, and viable/non-viable particle and moisture testing of compressed gases/air.

Essential Skills

• 2+ years of relevant experience with a High School diploma, or a BS degree, or a degree in a related field.
• Experience in quality control, microbiology, and environmental monitoring.
• Proficiency in EMPQ, gas, and water testing.
• Knowledge of GMP, cleanroom, aseptic techniques, bacteria, air sampling, and water sampling.

Additional Skills & Qualifications

• Prior experience in biopharmaceutical or pharmaceutical industry.
• Prior laboratory experience.
• Basic knowledge of current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
• Familiarity with general microbiology techniques such as gram staining, aseptic technique, and plate streaking.
• Knowledge of USP and other regulatory requirements.
• Understanding of HPLC and UPLC systems.
• Proficiency in Microsoft Office applications.
• Ability to work effectively in a team environment.
• Strong verbal, written, and interpersonal communication skills.
• Proficiency with MODAL/LIMS.
• Technical training on environmental monitoring of facility and utility systems.

Work Environment

Work within a GMP Manufacturing Suite, utilizing various technologies and systems relevant to the field. The role requires adherence to standard safety and cleanroom protocols.

Job Type & Location

This is a Contract position based out of Frederick, Maryland.

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 Oct 29, 2025.