The Microbiologist IV will head projects pertaining to Research and Development to include EM, product testing, and method development and validation, assist in regulatory compliance for the Microbiology laboratory with direction from Microbiology Management, and assist review all laboratory documents including Quality database maintenance, oversee equipment maintenance/calibration, assist in validation projects,, and provide feedback to the Microbiology management on overall laboratory performance. The Microbiologist IV is responsible for performing all the microbiological assays related to raw material, in-process, and final product testing in the Microbiology Laboratory as well as performing environmental monitoring of the manufacturing area when needed. Responsibilities include sampling, testing, and releasing of environmental monitoring results, sterility testing, endotoxin testing and microbial identification when needed. In addition to these responsibilities, the Microbiologist IV ensures that documentation and activities in the laboratory are compliant with all applicable regulations.
- Environmental Monitoring Completion
- Utilities completion
- Microbial Identification Completion
- Raw Material Testing including APIs
- Particulate Testing
- Endotoxin Testing
- Sterility Testing
- Growth Promotion
- Review
- Method Development Testing
- Special Projects
- Minimum 4 years’ experience in Sterility testing and endotoxin testing
Responsibilities:
- Responsible for maintaining all equipment related to sterility testing, and microbial culture and identification. Some of this equipment includes but is not limited to VHP Generator, Isolator, Biosafety Cabinets, microscope, etc. This includes all routine maintenance, preventative maintenance, and calibration.
- Responsible for coordinating microbiology assistance during R & D projects.
- Responsible for investigations as requested by the Microbiology Laboratory Management.
- Assists in writing laboratory SOPs and validation protocols.
- Documents raw and final data to ensure complete and proper documentation according to our procedures and applicable cGMPs.
- Assist in special projects and regulatory audits as requested by the Microbiology Management.
- Responsible for project tracking and timely completion as a project team leader including Research and Development projects and Validation projects.
- Training and assist of training new employees and existing personnel on all applicable SOPs and tasks.
- Assist in Review of all documents.
- Responsible for sampling, testing, and releasing all the sample points described in the Environmental Monitoring (EM) Program and utilities testing procedure.
- Responsible for ensuring all microbiological testing is performed in a sterile and/or aseptic environment.
- Responsible for performing the necessary preparation and testing needed for the maintenance of TRC’s Microbial Culture Collection (HMCC).
- Responsible for maintaining a biohazard free working environment.
- Responsible for the correct identification of microorganisms isolated from critical areas around the facility such as from product, media failures, and from the EM program when needed.
- Responsible for maintaining and sending microbial isolates to outside testing laboratories when needed or as requested by the Microbiology Management.
- Responsible for performing all microbiological tests associated with validations, such as cleaning or Operating Procedures, Safety and equipment validations.
- Responsible for performing all microbiological tests associated with product stability studies and Research and Development.
- Responsible for performing bioburden and LAL testing.
- Responsible for performing sterility testing on all final products or on any other samples as deemed necessary by the Microbiology Management.
- Responsible for the general maintenance of the Microbiology Laboratory (including Identification and warehouse area) including good housekeeping and a safe working environment.
- Follow Standard Operating Procedures, safety, health, and cGMP Guidelines.
- Responsible for troubleshooting, maintenance, and calibration of laboratory equipment.
- Order and maintain appropriate level of laboratory supplies.