Jobs search

Microbiologist

ReviveRX • Houston, Texas, United States • 1d ago

Department: Quality

Reports To: Sr. Manager, QC Sterility Assurance

Location: ReviveRX, Houston TX

Status: Non-Exempt

Position Type: Full-Time (Sunday-Thursday 9am-6pm)

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.