Quality Control Microbiologist Job at ClinLab Staffing, Houston, TX

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  • ClinLab Staffing
  • Houston, TX

Job Description

Duties and responsibilities

  • Evaluate QC Microbiology activities.
  • Responsible for testing and monitoring.
  • Participate in the environmental monitoring program and follow related established procedures.
  • Oversee the microbiology laboratory.
  • Manage the media and microbe qualification testing in support of EM and/or (Bioburden) sterility testing.
  • Develop study designs, data/statistical analysis, reporting results in both written and oral format (presentation).
  • Responsible for QC Micro material, data review, data trending, comparability, qualification/validation, compendial methods, etc.
  • Be able to draft Standard Operating Procedures (SOPs), protocols, reports, environmental monitoring excursions, OOS, investigations, etc.
  • Responsible for intra-departmental and inter-departmental collaboration and communication within QC, and with Procurement, Manufacturing and Quality Assurance.
  • Problem solving and troubleshooting Microbiology assay as necessary.
  • Other duties as assigned

Skills and Qualifications

  • B.S. or MS 2-4+ yrs. or Ph.D. in relevant field
  • Knowledge of ISO regulations specific to GMP cleanrooms and a good understanding of USP, EP guidelines associated with cell and gene therapies/ biologics.
  • Knowledge of compendial microbiological safety testing methods and requirements common to the pharmaceutical industry for bioburden & sterility, mycoplasma, endotoxin, etc., and experience with culturing and identifying various microorganisms (bacteria, yeast, fungi) by different methods (stains, PCR, etc.).
  • Experience in plating, reading and reporting results, microbial identification, identification of EM excursions, and trending.
  • Experience in CAPA and troubleshooting.
  • Ability to process large amounts of documentation in a timely and efficient manner.
  • Team-oriented, multidisciplinary, and multicultural environment.
  • Able to work flexible hours to meet deliverable deadlines.
  • Desire to take initiative on department-wide improvement projects and drive them to completion.
  • Experience with media and microbe qualification testing in support of EM and/or (Bioburden) sterility testing.
  • A detailed understanding of cGMP/GLP regulations as well as excellent cGDP skills to facilitate the completion of all Quality Control activities.
  • Familiarity with basic core QC areas including product/material stability, data review, data trending, comparability, qualification/validation, compendial methods, etc.
  • Excellent writing skills and experience in drafting Standard Operating Procedures (SOPs), protocols, reports, environmental monitoring excursions, OOS, investigations, etc.
  • Understanding/familiarity with relevant FDA, EMA, ICH, USP and EP guidelines and regulations associated with the quality control of biologic/cell therapies in general and the environmental monitoring and operation of cleanrooms, specifically.
  • Excellent interpersonal skills and willingness to work interdepartmentally with QC, Manufacturing and Quality Assurance.
  • Ability to solve problems and troubleshoot as necessary.

Working conditions

  • Must be able to fully gown-up for aseptic environment work.
  • Must be able to occasionally work on weekends and holidays.
  • In Office

Equipment

  • SAS Super 180 Air Sampler
  • QuantStudio 5
  • MET ONE 3445+
  • Microscopy
  • Endosafe® PTS™ or MCS™ Instrumentation

Job Tags

Work at office, Flexible hours, Weekend work,

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