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Quality Control Microbiologist: Becton Dickinson & Company (BD)

QC Microbiologist activities include routine micro testing to support product release, raw material release, facilities/utilities, production environment, and cleaning verification. Activities will also include managing method transfer activities internally and to external contract facilities. He/She will development of methods to support cleaning and raw materials is also required. This position supports the ongoing development, manufacture, and distribution of pharmaceutical products in compliance with local procedures, corporate policies, and the regulatory requirements of the U.S. Food and Drug Administration. This position will rely on experience and judgment in order to plan and accomplish goals.

Main Responsibilities:

- Routine micro testing of samples supporting incoming raw materials, in-process production, finished product, and validation

- Perform Bioburden, LAL, Sterility, TOC, and water analysis testing

- Perform sampling of water system and environment

- Performs instrument/method troubleshooting within method parameters and management guidance

- Perform investigations on out-of-specification results or alert/action situations

- Perform instrument qualification, calibration and preventive maintenance

- Perform disinfectant validation and analysis

- Perform Growth Promotion on media

- Maintain cultures stocks

- Perform microbial identification on environmental and material isolates

- Leads method transfer and method qualification for new products

- Leads method optimization and qualification for cleaning validation

- Maintain the data archives and samples

- Train technicians and other microbiologists on microbiology methods, instruments and documentation

- Logging and tracking of samples

- Documents/reviews laboratory work using laboratory notebooks/worksheets that is detailed, timely and in compliance with GLP/cGMP requirements

- Compiles data to support trending program

- Write, review and update standard operating procedures

- Order chemicals and laboratory supplies as needed

- Possess the ability to identify analyze, and work towards correcting potential hazards

- Maintains strictest standards of hygiene in laboratory area

- Performs other duties as assigned by area management

Required Skills and Knowledge - Bachelors degree microbiology or closely related scientific discipline. 3-5 years of relevant Microbiology experience, preferably in Quality Control, in a pharmaceutical manufacturing company. Experience and knowledge of sterilization process qualifications especially biological indicators quantification and preparation. Experienced/knowledgeable of pharmaceutical processing techniques such as aseptic manufacture. Excellent attention to detail and working knowledge of FDA Regulations/Guidance's, Good Laboratory Practices, Good Manufacturing Practices, and ICH Guidelines, USP/NF. Maintains a safe working environment. Excellent aseptic technique. Familiarity working with an isolator is desirable

Technical Area of Expertise - excellent verbal and written communication, organization, prioritization, displays sound judgment, problem-solving, interpersonal and analytical skills. Experience with FDA inspections. Understanding of basic statistical analysis
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