Quality Control Analyst - Environmental Monitoring - 1st Shift

Harmans, MD, US
Sep 14, 2019
Required Education
Bachelors Degree
Position Type
Full time
Paragon Gene Therapy, now a part of Catalent, hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives.

Paragon Gene Therapy, in Baltimore & Harmans, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses.

This role is responsible for Environmental Monitoring sampling, analyzing, and aseptic monitoring and microbiological testing to support Phase I/II/III and Commercial GMP manufacturing. Works in a fast-paced environmental supporting the quality control department of a CMO for manufacturing of biologic bulk drug substance, sterile finished drug product, and fill/finish.

Position work week is Monday through Friday, 1st shift.

Key responsibilities include but are not limited to:

  • Perform Environmental Monitoring of Grade B-D Cleanrooms, including sampling of viable surfaces, viable air and non-viable particulates in a Phase I/II/III/Commercial GMP Manufacturing facility.
  • Conducts routine sampling and testing of Clean Utilities such as USP water (WFI) and clean steam
  • Conducts bioburden testing on prepared buffers/solutions, equipment cleaning samples, in-process and release drug product samples.
  • Ability to isolate and sub-culture microorganisms for identification.
  • Provides input on SOP revisions and may assist in the creation and editing of protocols
  • Builds credibility within the lab group by performing high quality work
  • Works closely with manufacturing and QA to coordinate routine EM, changeover EM, and monitoring to support client campaigns
  • Performs Aseptic Process Simulations (media fills) and fill/finish monitoring which includes continuous monitoring of air quality, personnel aseptic technique, and environment integrity
  • Compilation and trending of Environmental Monitoring data for reporting purposes
  • Report and investigate environmental monitoring excursions.

Education & Experience:

  • Associate degree in a Life Sciences discipline required (Microbiology preferred) and 0-2 years of experience in GMP clean rooms with some or all of that in a QC Environmental Monitoring role
    working in cGMP cleanrooms
  • Experience with Microsoft Office
  • Strong attention to detail
  • Familiarity with Good Manufacturing Practices (cGMP's)
  • Have the knowledge and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks

Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.