Quality Control Analyst II - Microbiology

Location
Harmans, MD, US
Posted
Jul 20, 2019
Ref
1672
Hotbed
BioCapital
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.

The QC Analyst, Microbiology is actively engaged across multiple departments as well as within a dynamic project team. The Microbiologist must display strong technical knowledge, initiative, and scientific commitment, while making significant scientific and technical contributions within the quality control, quality assurance, validation, and manufacturing groups.

Key Responsibilities include but are not limited to:

  • Perform microbiological testing for buffers/solutions, in-process manufacturing samples, bulk drug substance and finished drug product samples.
  • Develop and perform validation testing of microbiological methods for client specific products and materials
  • Draft, review and revise microbiological procedures.
  • Document writing, data interpretation, results presentation, statistical analyses, and trending
  • Assist in developing a microbial contamination control plan and program, with a focus on sterility assurance and manufacturing drug products under controlled conditions
  • Assist in the tracking, trending, and identification of all facility microorganisms including cataloging and generating stock of facilities resident microflora
  • Evaluate manufacturing processes for potential to eliminate and limit bioburden (for example, HACCP or FEMA approach) as well as reviewing cleaning steps, equipment hold times, HVAC, control level of environments for critical tasks, open-system vs closed-system operations, and bioburden monitoring.
  • Perform cleaning and disinfection validation studies as wells as minimization of cleaning material residual control
  • Establish phase appropriate contamination control, gowning procedures, and operator training
  • Assist in implementation of industry best practices for Environmental Monitoring and the monitoring of clean utilities in the facility
  • Other duties as assigned

Experience & Education:

  • Bachelor degree in a Life Science field required; Microbiology preferred
  • 2 years of experience and knowledge in the pharmaceutical and/or biotech industry in sampling and testing of critical utilities and environmental monitoring within a GMP environment
  • Extensive experience performing USP testing such as bioburden, growth promotion, endotoxin, TOC and conductivity
  • Must be able to gown as required in Aseptic Manufacturing areas
  • Strong aseptic technique experience
  • Advanced knowledge of cGMPs, safety, proper documentation, and data integrity
  • Knowledge and application of GMP principles, and working in an FDA regulated environment
  • Strong communication skills: oral/written and listening


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.

#LI-EW1