Supervisor, Qc Microbiology

About the role

Responsible for the day-to-day operations of the QC Microbiology laboratory, including overseeing the environmental monitoring of classified spaces and the routine testing of the USP controlled utility systems and applicable microbiological assays of in-process samples and finished product. Ensures the timely testing and release of all samples.

Responsibilities

• Supervise lab personnel and provide oversight for personnel work schedules.
• Mentor and develop staff to meet technical and business needs.
• Perform trending and data analysis with appropriate statistical evaluation of environmental monitoring and water/clean steam data for NH PCI facility sites and write quarterly reports summarizing these data.
• Perform and document investigations into Environmental Monitoring excursions and incidents which occur during aseptic filling and routine monitoring.
• Perform risk assessments and investigations with effective CAPAs.
• Work with and provide input to Operations and Facilities groups to maintain the sterility or aseptic nature of processes.
• Perform initial identification of microbial contaminants and/or isolates.
• Oversee and perform as necessary endotoxin, bioburden, growth promotion of media, environmental monitoring, and critical utilities collection and testing.
• Coordinate and support validation, calibration, and maintenance of microbiology laboratory equipment and instrumentation.
• Maintain positive relationship and network effectively across sites, organizations, and clients.
• Ensure cGMP compliance of all activities performed and on-time delivery of quality results.
• Write and review standard operating procedures and coordinate method development and validation of microbiological methods.
• Work and guide personnel to assure test results, procedures, and methods are written, maintained, executed, and approved in accordance with regulatory guidance.
• Manages and develops subordinate staff, assigns responsibilities and duties within the group, and provides constructive feedback to team.
• Authors performance reviews within corporate timelines.

Requirements

• Master’s Degree in Microbiology, Biology, or similar life science preferred with at least 3-5 years’ experience in Pharma or Biotechnology Quality Control cGMP.
• Alternatively, a BS Degree in Microbiology, Biology, or similar life science with greater than 5 years of intensive experience may be considered.
• Minimum of 1-3 years demonstrated leadership experience within GMP QC Microbiology.
• Previous experience in aseptic manufacturing highly preferred.
• In-depth knowledge of US, EU, and other international regulations and guidelines associated with environmental monitoring programs.
• Proficient in statistical and data analysis.
• Strong oral and written communication skills.
• Excellent organizational skills and ability to multi-task.
• Able to work in a highly complex environment with competing demands and priorities.
• Able to deal with ambiguity.
• Self-motivated with a drive for excellence; able to inspire and motivate staff.
• Positive attitude and strong interpersonal skills.
• Honesty, integrity, respect, and courtesy with all colleagues.

Special Demands

• Must be physically capable to perform duties with or without reasonable accommodations.
• Able to gown and work in an ISO environment.
• Able to lift up to 20 lbs.
• May occasionally support off-shift activities.
• Travel less than 10%, generally consisting of routine daily movement between buildings.