QC MICROBIOLOGY LABORATORY SUPERVISOR
The Microbiology Lab Supervisor will oversee the microbiology function with a focus on a GMP environmental monitoring (EM) program which includes ISO class 5, 7, and 8 HVAC, EU Grade A to D, purified water, and compressed gases systems for a Quality Control Laboratory in a GMP facility that produces biopharmaceuticals (vaccines, biologics, viral vaccines, monoclonal antibodies, etc.). Responsibilities include EM data review, evaluation, reporting, and trending; investigations; scheduling in house and contract personnel; gowning training and annual qualification. Must ensure that the EM program meets regulatory and industry standards, and provide general microbiological expertise.
• Perform and/or oversee environmental monitoring for HVAC (viable air, viable surface, total particulates), purified water (conductivity, TOC, bioburden) and compressed gases (hydrocarbon, dew point and bioburden) systems. Serve as subject matter expert in this area.
• Provide direct supervision to at least one analyst or assistant including: scheduling, setting goals and objectives, training and ensuring development plans are in place. Address personnel issues promptly, interview and hire new candidates and complete performance reviews fairly and on-time.
• Review and trend EM data and publish quarterly and annual trend reports.
• Schedule testing and review data for accuracy, adherence to compliance and completeness.
• Conduct thorough investigations to determine root cause of environmental excursions and other nonconforming results and implement appropriate corrective and preventative actions in a timely manner.
• Liaise with other departments including Quality Assurance, Manufacturing and Facilities to address compliance issues and to implement corrective actions and to improve programs.
• Understand and apply current regulations (cGMP and EU).
• Perform microbiological testing such as bioburden, endotoxin, growth promotion, viability and gram staining, etc.
• Establish and maintain library of environmental isolates.
• Provide microbiological expertise to QC and to other departments as needed. Act as point of contact for training and qualifications.
• Perform or assist with the development and implementation of microbiological methods.
• Perform other established analytical methods such as HPLC, protein determination by A280 and BCA, Western blot, SDS-PAGE, ELISA, TOC, conductivity, pH, appearance testing to support QC operations.
• Perform QC Laboratory testing accurately and to schedule as per written procedures. Record all data, observations and QC results accurately with keen attention to detail onto controlled records to cGMP standards.
• Participate in client and internal audits, client calls and meetings. Address client requests and audit findings in a timely and appropriate manner.
• Participate in assay troubleshooting, qualification and validation.
• Oversee submission of samples to contract testing laboratories.
• Order and maintain laboratory reagents and supplies.
• Manage the use and maintenance of scientific equipment and instrumentation, computer systems; Ensure that they are kept in a calibrated / validated state and part 11 compliant.
• Maintain high level of cleanliness, organization and segregation in the QC Laboratory.
• Write and revise documents such as SOPs and technical reports.
• Assist in making continuous improvements to the QC systems.
• Perform other tasks as required or assigned.
KNOWLEDGE AND EXPERIENCE REQUIRED FOR THE JOB:
• B.A. or B.S. or MS degree in microbiology or related scientific field
• A minimum of 5-7 years related environmental monitoring and microbiology experience with biological products, in a GMP Quality Control laboratory.
• Experience performing EM, purified water and compressed gases sampling and testing for ISO classes 5, 7 and 8 a must.
• Experience with bioburden testing and qualification required.