Microbiologist Galaxypharma Albany, NY Job Details Full-time $70,000 - $90,000 a year 11 hours ago Benefits Health insurance Qualifications Biology USP 797 Pharmaceutical regulatory compliance Cleanroom protocols Personal protective equipment (PPE) adherence Manufacturing facility experience Bachelor's degree Sterile attire donning Cleanroom experience Quality control experience within pharmaceutical industry FDA regulations Documentation reviews Pharmaceutical manufacturing facility experience Full Job Description About the Role Galaxypharma is seeking a Microbiologist to support the quality unit of our 503B outsourcing facility. This role owns the microbiology program behind our sterile-to-sterile compounding operations, including environmental monitoring, sterility assurance, and media fills, in accordance with c

GMP, USP , USP , USP

, and all applicable

FDA 503B

regulations. Key Responsibilities Run the environmental monitoring program, including viable air, surface, and personnel sampling in ISO 5-8 areas, with trending and alert/action level reviews. Coordinate sterility, endotoxin, and microbial identification testing with our contract laboratory, and review results before batch release. Plan and support aseptic process simulations (media fills) and gowning qualifications. Lead or support investigations of excursions, out-of-specification results, and deviations, and help develop CAPAs. Support cleaning and disinfectant efficacy programs and cleanroom certification activities. Write and revise microbiology SOPs, protocols, and reports. Train compounding staff on aseptic technique and contamination control. Participate in FDA inspections, audits, and continuous improvement initiatives. Qualifications Bachelor's degree in Microbiology, Biology, or a related science. 2+ years of microbiology experience in a cGMP sterile manufacturing, 503B, or pharmaceutical QC environment. Working knowledge of USP , , , , and 21 CFR 210/211. Strong documentation and data review skills. Comfortable working in PPE/cleanroom garb for extended periods. Preferred Qualifications Master's degree in Microbiology. Experience with environmental monitoring data trending software or LIMS. Prior FDA inspection experience.

Pay:

$70,000.00 - $90,000.00 per year

Benefits:

Health insurance

Work Location:

In person