Job Title: QC Microbiologist
Location: Houston, TX- 77047
Duration: 4 months
Job Type: Contract
Work Type: Onsite
Pay Rate: $25 to $29.50/hr
Overview:
TekWissen group is a workforce management provider throughout the USA and many other countries in the world. Our client is a leading biotechnology company that combines technological expertise with world-class manufacturing and scientific insight to support the delivery of innovative medicines for a wide range of diseases. Specializing in pharmaceutical ingredients, bioscience, biopharmaceuticals, custom manufacturing, and cell and gene therapy, the company provides comprehensive services across the pharmaceutical, biotech, and life sciences sectors. It supports every stage of drug development, from early research to commercial production, and offers solutions in biologics, small molecules, and specialty ingredients. Committed to quality and innovation, the company serves as a critical partner in advancing therapeutic solutions and streamlining complex manufacturing processes, with a global presence that ensures access to scalable, flexible, and compliant technical expertise.
Summary
The purpose of this role is to support the Quality Control, Microbiology Safety Team conducting bioburden, microbial enumeration, endotoxin, sterility testing, and other tests as needed. The individual in this role will support assays associated with QC-Microbiology/EM, assist with OOS investigations, and general upkeep of the microbiology department-controlled areas.
Key responsibilities:
- Performance of USP 61, USP 71, USP63, USP85 assays or validated alternatives
- Performance of growth promotion testing on liquid and agar media, for lot release, as well as for APS & AMT growth promotions
- Execution of BET (endotoxin) testing using the WinKQCL-1000 platform
- Perform and monitor rapid sterility testing using the BacT/Alert platform
- Performance of microbiological assays for media, raw material, process intermediates, and final drug product lot release
- Assistance with maintenance of the laboratories, inventory of consumables, and equipment maintenance
- Support Lab Investigation, system suitability failures, OOS excursions, and deviations
- Participate in change control actions: Revise procedures and draft qualification reports
- Maintain compliance with all required training
- Perform other duties as assigned.
Required Qualifications
- Associate degree in field of Life Science required
- Bachelor Science in Microbiology or Bacteriology field of study preferred
- Working knowledge in Quality Control Microbiology and working knowledge in a cGMP environment
- Must have strong communication skills, both written and oral. In addition, must have proficiency in Microsoft Word and Excel
- Experience with at least one of the following a plus: Bioburden / Growth Promotion / Endotoxin testing / Microorganism Identification / Sterility Testing
- Demonstrated knowledge in general laboratory skills and microbiological assays, and aseptic test methods
- Prior experience with WinKQCL, LIMS, SAP, and TrackWise a plus
- Able to propose ideas during problem solving, root cause analysis, and process improvement events. Provides suggestions for improvement to documentation and workflows
- Provides timely, clear, and accurate updates without being prompted
- Records test results and maintains raw data and accurate laboratory records
- Dependable and able to work well within a team. Capable of effectively representing the department in meetings and on project teams
TekWissen® Group is an equal opportunity employer supporting workforce diversity.