Quality Control Microbiology Supervisor

Job Summary

We are seeking a Quality Control Microbiology, Supervisor to support our Cell Therapy Manufacturing Facility located in Memphis, TN. 

The Quality Control Microbiology, Supervisor requires working knowledge of Environmental Monitoring of Good Manufacturing Practices (GMP) cleanrooms including how to appropriately and effectively complete investigations of excursions. Familiarity with compendial microbiological testing methods for sterility, mycoplasma, endotoxin, etc., and experience with culturing and identifying various microorganisms (bacteria, yeast, fungi) by different methods (stains, PCR, etc.), is essential.

The following are responsibilities related to the Quality Control Microbiology, Supervisor position:

• Leads all activities associated with daily operations of the QC Micro Department.
• Oversee the performance of QC Analyst providing support and guidance by coaching areas of growth and development and recognizing and rewarding successes. 
• Reviews and maintains documentation and records for accuracy and compliance.
• Prepare for and actively participate in internal and external audits, investigations, and reporting.
• Provide direction and technical expertise to Micro team.
• Utilize common problem-solving tools and methodologies in processes and procedures for root cause analysis and resolution. 
• Seek to understand and operate within the department budget, cost, and profitability restraints, and ensure that materials meet regulatory requirements.
• Ensure timely response and closure of customer complaints.
• Conducts and leads meetings and communications effectively.
• Prepares and facilitates reporting, as requested by QC Micro Leadership Team.
• Manages KPI performance, goals, and objectives.
• Issues and traces necessary deviations, change controls, CAPAs, related to QC Micro Department.
• Review and approve QC Micro data for accuracy and compliance to applicable SOPs and Test Methods.
• Supports and coordinates special projects and other assignments related to QC Micro Department.
• Must be able to report onsite, work flexible hours, split shifts, during weekends and holidays as the operations of the business requires.
• Perform other duties as assigned.

Compensation Data

The pay range for this position is $74k-83,500.00k per year. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

Job Qualifications

The following are minimum qualifications related to the Quality Control Microbiology, Supervisor position:

• Bachelor's degree in biology or relevant scientific discipline
• 3-4 years of relevant Microbiology experience preferred or equivalent combination of education and experience
• Ability to supervise and manage the schedule of Analysts
• Ability and desire to take initiative on department-wide improvement projects and drive to completion.
• Experience performing and managing performance of Environmental Monitoring of GMP cleanrooms.
• Ability to process large amounts of paperwork in a timely and efficient manner. 
• Previous experience supervising/scheduling staff for a 24/7 operation desired.
• Experience with microbiology laboratory design requirements, setting up/equipping, and inventorying.
• Experience in culturing microbes and use of various classical microbiology and biochemical techniques such as gram stain, streak plate, spread plates etc.
• Experience in data/statistical analysis, data trending, reporting results and presenting data in group and client meetings.
• Excellent writing skills. Ability to draft Standard Operating Procedures (SOPs), protocols, reports, etc. Ability to write deviations, Environmental Monitoring investigations, OOS reports, CAPAs.
• Understanding of cGMP/GLP regulations as well as excellent GDP (documentation skills).
• Familiarity with relevant FDA, EMA, ICH, USP and EP guidelines and regulations associated with the quality control of aseptic processes, biologic/cell therapies in general and the environmental monitoring and operation of cleanrooms, specifically.
• Excellent interpersonal skills and willingness to work interdepartmentally with QC, Manufacturing and Quality Assurance.
• Ability to multitask, problem solve and troubleshoot as necessary.