Quality Control Microbiology Analyst II

As a Quality Control Microbiology Analyst II, you will play a vital role in supporting the production of AAV Viral Vector Gene Therapy Drug Products. Your responsibilities include performing Environmental Monitoring sampling and conducting microbiological testing on raw materials, in-process, and finished drug product samples.

Responsibilities

• Perform Environmental Monitoring of Grade C/D Cleanrooms and aseptic filling isolators, including sampling of viable surfaces, viable air, and non-viable particulates in a Phase III/Commercial GMP Manufacturing facility.
• Conduct routine sampling and testing of Clean Utilities such as Water for Injection and Clean Compressed gasses.
• Conduct bioburden/endotoxin testing on raw materials, buffers/solutions, in-process, and release drug product samples.
• Provide input on SOP revisions and assist in the creation and editing of procedures and work instructions.
• Collaborate closely with manufacturing and QA to process specific environmental monitoring, product change over, and facility restart/recovery activities.
• Isolate and sub-culture microorganisms for identification and routine trending.
• Compile and trend Environmental Monitoring data for reporting purposes.
• Report and investigate environmental monitoring excursions.
• Demonstrate flexibility in following unique campaign requirements that may include off-hour and weekend work.

• Experience in a cGMP environment with a B.S. or A.S. in a Life Sciences discipline preferred.
• 2 years of relevant experience working in cGMP Quality Control.
• Proficiency in Environmental Monitoring of Clean Rooms and Clean Utilities.
• Knowledge of USP and EP microbiological testing requirements for bioburden and endotoxin testing preferred.
• Understanding of Good Manufacturing Practices (cGMPs).
• Strong attention to detail and organizational skills.
• Ability to apply basic scientific and regulatory principles to solve operational and routine quality tasks.
• Capability to work in a team-oriented environment under dynamic conditions.

• Experience or training in aseptic techniques and manufacturing gowning.
• Familiarity with EM and water sampling.

This role requires adherence to all federal and local regulations, laboratory health and safety procedures, and company Standard Operating Procedures, policies, and guidelines. Laboratory work will be conducted with some exposure to chemicals in a biosafety level 1 laboratory, necessitating personal protective equipment. Essential physical requirements include the ability to move less than 5 lbs daily, occasionally lift and push boxes of dry ice weighing approximately 50 lbs, and lift and move up to 25 lbs with or without reasonable accommodations. The position involves working in a shared lab/office space.

Job Type & Location

This is a Contract position based out of ROCKVILLE, MD.

Pay and Benefits

The pay range for this position is $30.00 - $40.00/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 ROCKVILLE,MD.

Application Deadline

This position is anticipated to close on Dec 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 for other accommodation options.

Salary : $30 - $40