Supervisor, Microbiology

This is a working Supervisor role and responsible for overseeing the routine operations and perform testing such as sterility testing, endotoxin testing, media growth promotion, environmental monitoring, plate reading, data review, microbiology investigations, and other microbiology methods as needed to support product release. This position also assists in site and method qualification, validation and commissioning activities. This position works closely with contract labs and vendors to manage outsourced testing. 

Responsibilities

• Oversee day to day operations in the QC Microbiology laboratory in support of environmental monitoring and batch related microbiology testing on the weekend shift.
• Perform daily cGMP quality control laboratory microbiological testing activities and environmental monitoring of the cleanroom areas at the facility as required.
• Schedule and perform routine gas sampling at the facility as required.
• Perform data analysis and result reporting of microbiology assays to support product lot release with adherence to turnaround times.
• Oversee growth promotion testing of microbiological media using both ATCC and in-house isolates.
• Oversee environmental monitoring of the manufacturing areas, including batch related EM, is performed accurately and according to the manufacturing schedule.
• Ensure all in-process and lot release microbiology testing is performed and reviewed accurately and timely.
• Ensure timely review of routine environmental monitoring data, microbiology testing data, and excursions and OOS reports are completed accurately and timely.

Requirements 

• Bachelor’s degree in Biology, Microbiology or related scientific field is required
• Minimum 3 years of experience in in a cGMP Quality Control microbiology role
• Prior experience in managing a team and having direct reports.
• Basic knowledge of Compendial (e.g., USP, EP, JP, ) requirements and standards
• High proficiency in aseptic techniques when executing microbial test methods and environmental monitoring
• Proficient in performing technical writing (e.g., test methods, SOP's, protocols, deviations )

This position supports manufacturing and work a 10-hour weekend shift:

• Sun-Wed
  • 1400-1230 (02:00PM-12:30AM)

OR

• Wed-Sat
  • 1400-1230 (02:00PM-12:30AM)