Microbiology and Sterilization Analyst

Support the Quality Assurance Laboratory through microbiological testing, environmental monitoring, and sterilization assurance activities to ensure product quality, patient safety, and regulatory compliance. Perform testing of raw materials, finished products, manufacturing environments, and sterilization processes while maintaining accurate documentation in accordance with GMP, GDP, and quality system requirements.

Schedule: Monday through Friday, 9:00 AM to 5:30 PM. Additional hours may be required based on business needs.

KEY RESPONSIBILITIES

• Perform microbiological testing on raw materials, finished products, and manufacturing environments to ensure compliance with quality specifications.
• Conduct environmental monitoring activities in classified cleanrooms and GMP manufacturing areas.
• Support sterilization assurance programs, including protocol execution and testing associated with ethylene oxide (EO) sterilization processes.
• Perform EO/ECH residual testing on terminally sterilized medical devices using gas chromatography (GC-FID).
• Aseptically handle microbial cultures and laboratory samples following established procedures.
• Investigate test results, analyze data, and prepare technical reports.
• Create, revise, and maintain Standard Operating Procedures (SOPs), laboratory forms, and related documentation.
• Verify laboratory equipment and maintain laboratory supplies, chemicals, and inventory.
• Maintain compliance with GMP, GDP, safety, environmental, and quality system requirements.
• Communicate results, observations, and issues effectively with laboratory, quality, and manufacturing teams.
• Support continuous improvement initiatives and perform other duties as assigned.

QUALIFICATIONS

• Candidates must have an associate degree or equivalent background in STEM areas including Biology, Microbiology, Chemistry, Biotechnology, Life Sciences, Engineering, or another scientific field. Alternatively, individuals holding a bachelor's degree or equivalent experience in a STEM subject along with laboratory, manufacturing, quality, or regulated industry experience are eligible.
• Strong attention to detail with the ability to accurately document and analyze laboratory data.
• Ability to work safely and effectively in laboratory and cleanroom environments.
• Strong written and verbal communication skills.
• Proficiency with Microsoft Office applications.

Preferred Qualifications

• Experience in a microbiology, quality, pharmaceutical, medical device, biotechnology, laboratory, or other regulated manufacturing environment.
• Experience working in GMP and/or cleanroom environments.
• Experience conducting microbial evaluations, environmental assessments, sterilization processes, and/or gas chromatography.
• Knowledge of laboratory investigations, technical report writing, and quality systems.
• Strong analytical and problem-solving skills with the ability to work independently and collaborate effectively with cross-functional teams.