Job Title: QC Microbiologist

Job Description

The QC Microbiologist performs essential testing and monitoring tasks under minimal direction. Responsibilities include raw material testing, finished product testing, stability testing, water testing, environmental monitoring, equipment cleaning sample testing, media handling, growth promotion of media, microbial identification, and other microbial testing as needed.

Responsibilities

• Conduct routine microbial examination testing for raw materials, finished products, and water systems.
• Perform cleaning swab samples testing and environmental monitoring as needed.
• Complete work in accordance with GLP and cGMP documentation practices.
• Write, update, and evaluate test results.
• Generate Certificates of Analysis for materials and finished products.
• Follow environmental, health, and safety policies and procedures.
• Perform other duties as assigned or as business needs require.
• Work overtime and weekends when required.
• Perform microbial examination tests for equipment cleaning, including streak samples and incubation of plates.
• Conduct microbial counts and microorganism identification, including testing for yeast and mold.
• Report results on data sheets and generate Certificates of Analysis.

Essential Skills

• Proficiency in environmental monitoring and microbiology.
• Experience in stability testing, raw material testing, and in-process analysis.
• Knowledge of aseptic techniques and quality control practices.
• Familiarity with GMP and laboratory procedures.
• Ability to conduct microbial testing, media handling, microbial identification, and water testing.
• Experience with streak samples, incubation, stability studies, and batch record review.

Additional Skills & Qualifications

• B.S in microbiology, biology, or related life science.
• Experience in conducting stability studies and batch record reviews.
• Ability to perform root cause analysis of OOS, deviations, or complaints.
• Audit experience.
• Experience with method qualification and validation.

Work Environment

The role is based in Easton, MD, within a dynamic pharmaceutical solutions provider focused on contract packaging, repackaging, and manufacturing for the pharmaceutical, OTC, dietary supplement, animal health, and medical device marketplaces. The position requires standing for extended periods, walking up and down stairs, and lifting weights between 5-10 lbs.