QC Analyst II-UTR-AKS-JAN-25-16

Company: Software Galaxy Systems, LLC
Location: Houston
Posted on: February 21, 2025

Job Description:

Contract - 05 months + (Possibilities of Extension)

All the relevant skills, qualifications and experience that a successful applicant will need are listed in the following description.

The QC Analyst II will support the Quality Control, Microbiology Safety Team by performing bioburden, microbial enumeration, endotoxin, sterility testing, and other microbiological assays. The role will assist with OOS investigations, maintaining laboratory equipment, and ensuring compliance with cGMP regulations. The ideal candidate will have experience with USP testing methods and a background in microbiology.

Job Responsibilities:

Perform USP 61, USP 71, USP 63, and USP 85 assays, as well as validated alternatives.
Conduct growth promotion testing on liquid and agar media for lot release and APS & AMT growth promotions.
Execute BET (endotoxin) testing using the WinKQCL-1000 platform.
Perform and monitor rapid sterility testing using the BacT/Alert platform.
Conduct microbiological assays for media, raw materials, process intermediates, and final drug product lot release.
Assist in maintaining the laboratory, including inventory management, consumable stock, and equipment upkeep.
Support investigations into system suitability failures, OOS excursions, and deviations.
Participate in change control actions, revise procedures, and draft qualification reports.
Ensure compliance with all required training and follow safety procedures.
Perform additional duties as assigned.


Skills:

Strong attention to detail, organization, and time management skills.
Working knowledge of USP 71, BacT/Alert platform, and endotoxin testing.
Familiarity with bioburden, growth promotion, sterility testing, and microbiological assays.
Proficient in Microsoft Word and Excel.
Experience with WinKQCL, LIMS, SAP, and TrackWise is a plus.
Excellent communication skills, both written and verbal.
Ability to contribute to problem-solving, root cause analysis, and process improvement.
Dependable team player who can effectively represent the department in meetings.


Education/Experience:

Associate degree in Life Science required.
Bachelor's degree in Microbiology or Bacteriology preferred.
Working knowledge in Quality Control Microbiology and experience in a cGMP environment.
Prior experience with microbiological assays and aseptic test methods is a plus.
Ability to record accurate test results and maintain raw data and laboratory records.
Strong analytical and problem-solving abilities

Keywords: Software Galaxy Systems, LLC, Houston , QC Analyst II-UTR-AKS-JAN-25-16, Professions , Houston, Texas