Website Goodwin Biotechnology

Scope of Function:  Provides microbiological support for all manufacturing and support activities. Participates in activities such as environmental monitoring, media fills, microbiological and chemical sampling of utilities and services, and other tasks as assigned. Performs microbiological and related testing including, but not limited to, bio burden BET, MLT, Microbial Identification, Sterility, TOC, pH, Conductivity, Utility Monitoring, and Growth Promotion. Perform quarterly and annual data analysis, archiving and trending of Environmental Monitoring and utilities data. Serves as mentor to member(s) of the Microbiology staff.

Reports to:  Quality Control Microbiology Supervisor

 

Specific Duties:

  • Understand and perform microbiological techniques including, but not limited to, Bio burden, Sterility, Endotoxin, TOC, Water Testing, Environmental Monitoring, Growth Promotion and visual inspections
  • Create or revise departmental SOPs
  • Maintain the quarterly report for the Microbiology lab tracking all Alerts, Actions, or OOS
  • Perform all relevant microbiology tests and reports
  • Maintain, review and approve all equipment log books associated with the Microbiology Lab
  • Keep Microbiology area in a tidy, organized and in a sanitary condition at all times
  • Ensure that all supplies related to microbiological monitoring and testing are maintained in sufficient quantities and within shelf-life
  • Create, execute and compile verification protocols and reports related to Microbiology
  • Leads laboratory investigations for out of specification (OOS) microbiological testing results, and other microbiological laboratory non-conformances
  • Prepare deviations, investigations, OOS, change control, work orders and test reports
  • Excellent verbal and written communication skills
  • Assist in ordering/inventory of lab supplies
  • Subject Matter Expert regarding aseptic technique and processing and contributes to related training
  • Optimize procedures and methods in relation to microbiological monitoring
  • Maintains microbiological results and reports, tracks, trends and metrics ad hoc and per established schedules
  • Monitor compendia and other standards to ensure procedures and processes are current with industry standards
  • At the request of Quality Assurance Department, assist in vendor audits
  • Maintains currency with FDA, EMA and other CGMP standards and industry trends

 

Education and Experience: 

  • BS in a scientific discipline
  • Minimum three to five years working in a FDA/EMA regulated environment
  • Excellent writing skills, judgment, integrity, investigation (as in OOS), ability to work independently

Interacts with: 

  • Vendors for supply acquisition
  • Clients during site visits in regard to microbiology matters
  • Manufacturing and Quality departments