Microbiologist

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.