Responsibilities:

• The Microbiological Control (MC) Laboratory supports the onsite small scale commercial manufacturing facility.
• The QC Microbiology Laboratory Technician conducts routine microbiological laboratory testing of raw materials and products for in-process, release and stability samples in compliance with methods, procedures, protocols and regulatory requirements.
• The QC Microbiology Laboratory technician performs lab analysis of environmental and utility samples and identification of microorganisms according to defined procedures.
• Perform laboratory analysis of samples, using aseptic technique, following established procedures and in full compliance with official compendia, health authority regulations, and established BMS policies.
• Conduct qualification of methods and/or other laboratory studies, according to scientific protocols.
• Maintains accurate records of work performed and documents results, according to good documentation practices and established procedures as well as perform data entry into LIMS.
• Assist with review of worksheets, as assigned.
• Assists in the investigation of OOS results in areas of assigned responsibility.
• Operates and maintains laboratory instruments, while ensuring the reliability of instrumentation through proper maintenance, with ability to troubleshoot minor issues.
• Must analyze, evaluate, and interpret data, notifying clients of results, and assisting to resolve issues, if applicable.
• Identify opportunities for workflow and procedural improvements.
• Promotes quality, safety and health, by ensuring clean work area, and adherence to procedures and safety culture.
• Must participate in continuous improvement using lean principles to assist with streamlining and making the laboratory efficient.
• Work schedule includes weekends and holidays.
• Work Hours: Monday to Friday 8 AM to 4 PM, weekends and holidays as needed

Qualifications:

• B.S. degree in Biological Sciences or related field with 0-3 years of QC microbiology laboratory experience preferred
• Knowledge of aseptic technique, environmental monitoring, and microbiological Quality Control testing and procedures preferred.
• Has excellent manual dexterity and aseptic technique.
• Has ability to complete sampling or testing assignments in a timely and compliant manner, with minimal supervision.
• Perform limited interpretation of data.
• Demonstrate ability to handle multiple assignments simultaneously and complete assignments in a timely and compliant manner, with minimal supervision.
• Knowledge of cGMPs and compendia testing required.
• Must have effective verbal and written communication skills.

• Some experience or knowledge with the following skills and/or experience:

• • Aseptic Technique
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• BioSafety Cabinets (BSC)

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• Knowledge about bioburden or endotoxin testing

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• GDP and GLP exp

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• PCR or Molecular chain testing

• The Microbiological Control (MC) Laboratory supports the onsite small scale commercial manufacturing facility.
• The QC Microbiology Laboratory Technician conducts routine microbiological laboratory testing of raw materials and products for in-process, release and stability samples in compliance with methods, procedures, protocols and regulatory requirements.
• The QC Microbiology Laboratory technician performs lab analysis of environmental and utility samples and identification of microorganisms according to defined procedures.
• Perform laboratory analysis of samples, using aseptic technique, following established procedures and in full compliance with official compendia, health authority regulations, and established BMS policies.
• Conduct qualification of methods and/or other laboratory studies, according to scientific protocols.
• Maintains accurate records of work performed and documents results, according to good documentation practices and established procedures as well as perform data entry into LIMS.
• Assist with review of worksheets, as assigned.
• Assists in the investigation of OOS results in areas of assigned responsibility.
• Operates and maintains laboratory instruments, while ensuring the reliability of instrumentation through proper maintenance, with ability to troubleshoot minor issues.
• Must analyze, evaluate, and interpret data, notifying clients of results, and assisting to resolve issues, if applicable.
• Identify opportunities for workflow and procedural improvements.
• Promotes quality, safety and health, by ensuring clean work area, and adherence to procedures and safety culture.
• Must participate in continuous improvement using lean principles to assist with streamlining and making the laboratory efficient.
• Work schedule includes weekends and holidays.
• Work Hours: Monday to Friday 8 AM to 4 PM, weekends and holidays as neede