Department: Quality

Reports To: Sr. Manager, QC Sterility Assurance

Location: ReviveRX, Houston TX (Onsite)

Status: Full-Time, Exempt

·       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.

·       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.

·       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.

·       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.