Job Description
As the Quality Control Analyst II – Microbiology, you will support the manufacture of AAV Viral Vector Gene Therapy Drug Products by performing Environmental Monitoring sampling and microbiological testing of raw materials, in-process, and finished drug product samples.
ResponsibilitiesPerform 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.Work 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.Follow unique campaign requirements that may include off-hour and weekend work.Essential SkillsExperience in a cGMP Quality Control environment.Experience with Environmental Monitoring of Clean Rooms and Clean Utilities.Experience with USP and EP microbiological testing requirements for bioburden and endotoxin testing preferred.Understanding of Good Manufacturing Practices (cGMPs).Strong attention to detail and strong organizational skills.Ability to apply basic scientific and regulatory principles to solve operational and routine quality tasks.Ability to succeed in a team-oriented environment under dynamic conditions.Additional Skills & QualificationsB.S. or A.S. in a Life Sciences discipline preferred.2 years of relevant experience working in a cGMP environment.Work Environment
Employees must adhere to all federal and/or local regulations, laboratory health and safety procedures, and all company Standard Operating Procedures, policies, and guidelines. Lab work will be conducted with some exposure to chemicals in a biosafety level 1 laboratory requiring personal protective equipment. Essential physical requirements include the ability to move less than 5 lbs of weight daily, lift and push boxes of dry ice weighing roughly 50 lbs infrequently, and lift and move up to 25 lbs with or without reasonable accommodations. Must be able to work in a shared lab/office space.
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 Feb 11, 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.
Diversity, Equity & InclusionAt Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our peopleThe 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 actalentaccommodation@actalentservices.com for other accommodation options.