The Microbiologist’s primary responsibility will be to support quality systems as they relate to the manufacturing and testing of cGMP drug products. These duties will include, but not limited to providing general laboratory support for raw material, in-process, stability, and finished product testing.
- Performs sampling of water pure steam to support manufacturing activities
- Performs Environmental Monitoring of aseptic filling rooms and supporting areas
- Performs Compressed Air and Gas Sampling and Testing
- Perform sampling to qualify Manufacturing operators for aseptic gowning
- Performs bioburden testing of water an in-process samples to detect microorganisms and to obtain information on types and levels of microbial contamination.
- Performs Total Organic Carbon, Endotoxin, Nitrate, and Conductivity testing on water
- Maintains laboratory equipment – cleaning and calibration
- Performs daily, weekly, and monthly lab maintenance and stocks supplies
- Receives incoming samples for testing
- Performs incoming material testing and inventory
- Performs Swab sampling and testing of manufacturing equipment
- Prepares Reagents and Standards used for testing
- Performs Bioburden and Endotoxin testing on client specific raw materials, in-process samples, and finished products.
- Performs testing on biological indicators to support Validation studies
- Data entry of results generated by Laboratory
- Complies with applicable GMPs.
- Maintain good practices with regards to processes and /or internal conditions leading to an aseptic environment.
- Maintains laboratory logbooks and other forms to document proper GLP testing.
- Reviews Logbooks
- Perform all job responsibilities in compliance with applicable regulations, standard operating procedures, and industry practice.
- Open to a flexible and fluid work environment. Work on any assignment as directed.
BS or BA in Microbiology or related field with a minimum of 2 years of experience within a pharma, biopharma and/or biotech manufacturing environment (prefer aseptic filling environment experience).
- Ability to interpret and relate Quality standards for implementation and review
- Proficiency in aseptic technique
- Proficiency in both written and verbal communication and presentations
- Must have strong interpersonal skills and be a team player
- Energetic, self-motivated, organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment
- Results oriented with sense of urgency
- Ability to work well in a cross functional team environment
- Must have proficient computer skills in Microsoft Word, Excel and Outlook
If you would like to be considered, please submit your resume on our careers page.