Quality Control Microbiologist
Performed testing to support release of raw materials, in-process materials and finished products (Allegra D24, Carafate Suspension & Gaviscon). Worked cross functionally to mitigate batch losses.
- Evaluated samples for the presence of objectionable microbial organisms using manual techniques and automated Vitek II Microbial Identification System.
- Conducted environmental monitoring and water testing in critical manufacturing & packaging areas. Met 100% annual analyst proficiency requirements.
- Prepared microbiological growth media & solutions and ensured media performance through QC testing.
- Performed annual temperature mapping re-qualification (Validator 2000) of facility autoclaves and temperature control systems.
- Knowledgeable in antimicrobial effectiveness testing (AET) of stability samples.
- Wrote and executed validation protocols (IQ/OQ/PQ) for evaluation and implementation of new automated laboratory equipment.
- Represented microbiology lab during FDA, EP and JP regulatory audits.
- Wrote quarterly & annual reports for USP Purified Water and environmental trending data.