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Microbiologist
MicrobiologistReviverx & Ways2well • Houston, Texas, United States
Microbiologist

Microbiologist

Reviverx & Ways2well • Houston, Texas, United States
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Department : Quality

Reports To : Sr. Manager, QC Sterility Assurance

Location : ReviveRX, Houston TX (Onsite)

Status : Full-Time, Exempt

Schedule : Sunday-Thursday 07 : 00AM-04 : 00PM (Training Monday-Friday 07 : 00AM-04 : 00PM)

Position Summary :

The Microbiologist role responsible for executing complex microbiological testing, interpreting data, and providing technical insight on contamination trends and sterility assurance in a pharmaceutical or compounding environment. This individual takes a more autonomous role in the laboratory and may contribute to method development, training, and quality investigations.

Essential Duties and Responsibilities :

  • Perform advanced microbiological assays, including microbial identification testing.
  • Lead or support environmental monitoring programs, trend analysis, and risk assessments.
  • Serve as subject matter expert (SME) for routine microbiological procedures and aseptic gowning.
  • Investigate out-of-specification (OOS) results, excursions, and contribute to CAPA documentation.
  • Author and review microbiology protocols, reports, and SOPs.
  • Support validation and qualification efforts (e.g., cleanroom requalification, growth promotion, media fills).
  • Mentor or train junior microbiologists or QC staff as required.
  • Evaluate and recommend improvements to microbiology workflows or contamination control programs
  • Conduct environmental monitoring (viable and non-viable) in classified cleanroom areas.
  • Perform and document basic microbiological assays such as gram-staining and microscopy under supervision
  • Operate and maintain laboratory equipment (e.g., incubators, biological safety cabinet, viable air tester, particle counter)
  • Perform media growth promotion testing and incubation logging in accordance with quality protocols.
  • Support cleanroom qualifications including environmental excursions and alert / action limit investigations
  • Maintain microbiological records, logbooks, and testing documentation with accuracy and compliance.
  • Follow established quality procedures and contribute to contamination investigations, as needed.
  • Collaborate cross-functionally with QA, Production, and QC teams to support timely testing and release.

Qualifications :

Education & Experience :

  • Bachelor’s degree in Microbiology or Biology required; Master’s degree preferred.
  • —       OR a Bachelor’s in a scientific field with a minimum of 5 years of microbiology experience in a GMP pharmaceutical or compounding environment.

    Knowledge, Skills & Abilities :

  • Understanding of microbiological fundamentals including aseptic technique and contamination control.
  • Familiarity with basic laboratory instrumentation and GMP / GLP documentation standards.
  • Detail-oriented with strong organization, documentation, and time management skills.
  • Ability to follow SOPs and maintain compliance with FDA and USP standards.
  • Proficiency in Microsoft Office Suite (Word, Excel, Outlook).
  • Ability to work in a cleanroom and laboratory setting for extended periods. Ability to interpret cGMPs and apply to non-routine situations
  • Must be flexible and able to manage and prioritize multiple tasks and assignments
  • Must have excellent interpersonal, verbal, and written communication skills and comfortably and clearly articulate issues with peers and colleagues at all levels in the organization.
  • Work Environment & Physical Requirements :

  • Must be able to gown and work in ISO 5–8 environments regularly.
  • Able to lift up to 25 lbs and work in laboratory and cleanroom settings for extended periods
  • Use of laboratory chemicals and exposure to microbiological agents with required PPE.
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