Microbiologist / QC Microbiologist

We are seeking an experienced Microbiology professional to support Quality Control and Quality Assurance activities within a GMP-regulated manufacturing environment. The successful candidate will perform and review microbiological testing, analyze and trend results, support environmental monitoring programs, and prepare technical documentation to ensure compliance with applicable GMP, GDP, regulatory, and compendial requirements.

Responsibilities:

• Perform and review microbiological testing and analytical assessments of raw materials, intermediates, and finished products.
• Perform microbial trending, data analysis, and assessment of acceptable and OOS results.
• Evaluate and review environmental monitoring and particulate monitoring results.
• Assist with microbiological test method development, validation, transfer, and remediation activities.
• Prepare and review microbiological technical reports, protocols, risk assessments, investigations, and other technical documents.
• Support CAPA, deviation, OOS, and change control activities, including investigation and technical documentation.
• Conduct documentation reviews and provide microbiology expertise as a Subject Matter Expert (SME).
• Research and evaluate applicable regulatory and compendial requirements to maintain compliance.
• Author, revise, and maintain SOPs and other controlled documents using established change control processes.
• Support audit and inspection readiness through documentation review, data trending, and CAPA completion.
• Ensure laboratory testing and documentation comply with GMP and GDP requirements.

Qualifications:

• Experience working in a GMP-regulated pharmaceutical, biotechnology, medical device, or other regulated manufacturing environment.
• Hands-on experience with QC microbiology and microbiological testing.
• Experience with Environmental Monitoring (EM) programs and microbial trending.
• Working knowledge of GMP, GDP, and laboratory quality systems.
• Experience with CAPA, OOS investigations, deviations, risk assessments, and change controls.
• Knowledge of microbiological method development and/or validation.
• Understanding of USP and other applicable compendial standards.