Quality Control Microbiology Analyst II

2 weeks ago

Rockville, United States Actalent Full time
Job DescriptionJob DescriptionJob Title: Quality Control Microbiology Analyst II
Job Description

As the Quality Control Microbiology Analyst II, 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.

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 gases.
  • Conduct bioburden/endotoxin testing on raw materials, buffers/solutions, in-process, and release drug product samples.
  • Provide input on SOP revisions and assist in creating and editing procedures and work instructions.
  • Work closely with manufacturing and QA to process specific environmental monitoring, product changeover, 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 Skills
  • Experience or A.S. in a Life Sciences discipline preferred with 2 years of relevant experience in a cGMP environment.
  • Experience working in cGMP Quality Control.
  • 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 organizational skills.
  • Knowledge and 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 & Qualifications
  • Experience with Environmental Monitoring, Water sampling, wifi sampling, Aseptic technique, and manufacturing gowning.
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. Must be able 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.

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 & Inclusion

At 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 people

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 actalentaccommodation@actalentservices.com for other accommodation options.

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