Position Summary
The Group Lead will perform and schedule Microbiological laboratory testing associated with Environmental Monitoring (EM), Water for Injection (WFI), and product specific Microbiological samples. Additionally, the Group Lead will be trained to perform Environmental Monitoring (EM) and Water for Injection (WFI) sampling in support of cGMP manufacturing activities associated with sterile manufacturing. This position will work day shift hours Monday-Friday and weekends as needed. The Group Lead will lead Microbiologists and support manufacturing operations by coordinating daily tasks, training, and projects as directed by the Supervisor and/or Manager. The Group Lead will report directly to the Supervisor.
Job Responsibilities
The Group Lead is expected to follow all policies and procedures which include but are not limited to; Standard Operation Procedures (SOPs), Work Instructions (WI), current Good Manufacturing Practices (cGMPs), and current Good Laboratory Practices (cGLPs). The Group Lead will be able to work under the Supervisor to accurately identify testing priorities which include but are not limited to the following:
- Perform bioburden testing for In-Process products and raw materials to assess potential microbiological contaminants.
- Perform bioburden testing for Water for Injection (WFI), City Water, and Reverse Osmosis Water (RO) to assess potential microbiological contaminants.
- Perform Endotoxin testing for In-Process products, Aseptic/Terminally Sterilized products, and Raw Materials.
- Perform Total Organic Carbon (TOC), Conductivity, and Endotoxin testing on Water for Injection (WFI) and Clean Steam samples.
- Perform sterility testing of Aseptic and Terminally Sterilized products.
- Perform Microbiological Organism Identifications to the genus and species level.
- Perform Growth Promotion/Quality Control Testing of Microbiological media and/or materials used for Microbiological sampling and testing.
- Perform Biological Indicator testing to support Validation studies/qualifications.
- Read plates generated from Environmental Monitoring and Microbiological Laboratory testing.
- Operate an Autoclave to perform sterilization and decontamination cycles and equipment, media, and biohazard waste.
- Perform daily and weekly laboratory cleaning requirements.
- Disposal of hazardous waste and non-hazardous waste following applicable EHS training.
- Perform sampling of Water for Injection (WFI), City Water, Reverse Osmosis Water (RO), and Clean Steam to support manufacturing and/or qualification activities.
- Perform Personnel Monitoring of sterile garbed personnel.
- Perform Compressed Air and Compressed Gas sampling to support manufacturing and/or qualification activities.
- Perform Viable Air, Total Particulate Air (Non-Viable), Surface (RODAC), and Swab sampling to support manufacturing and/or qualification activities.
- Perform Standard Operating Procedure (SOP) revisions.
- Perform Microbiological Deviation Investigations, Corrective and Preventative Actions (CAPAs), and Change Requests (CRs).
- This position may be involved with the transportation and handling of hazardous waste; must successfully complete Resource Conservation Recovery Act (RCRA) training within 1 year of hire, and annually thereafter.
Experience Requirements
- Minimum of 3 years of related laboratory experience, academic or otherwise
- Knowledge of aseptic techniques
- Knowledge of cGMP
- Experience in activities pertaining to aseptic manufacturing and knowledge of how to maintain an aseptic environment.
- Ability to multi-task, work under pressure with time constraints
- Must be flexible and able to adapt to changes in task priority.
- Excellent communication skills and ability to work independently to complete tasks.
- Ability to aseptically certify for sterile gowning entry.
Education Requirements
- Bachelor of Science (BS) Degree in Microbiology, Biology, or related Life Sciences.
EOE, including disability/vets.
|
