Essential Functions and Responsibilities
- Perform daily cGMP quality control laboratory microbiological testing activities at the facility.
- Perform environmental monitoring of the cleanroom areas as scheduled.
- Perform data analysis and result reporting of microbiology assays to support product lot release with adherence to turnaround times.
- Perform all activities with respect to cGMP compliance.
- Support thorough cGMP investigations for out-of-specification test results.
- Perform Environmental monitoring Data trending.
- Support technical problem solving.
- Support product stability programs including execution of stability testing, stability data analysis, and final reporting of stability data.
- Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results.
Required Education, Skills, and Knowledge
- Bachelor’s degree in a relevant discipline (biological sciences or equivalent)
- Minimum 2 years’ experience in the pharmaceutical industry within a Quality Control role; experience with cell therapy products is a plus.
- Successfully interface with multi-disciplined teams
- Extremely detail-oriented with strong technical skills
- Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
- High level of ownership and accountability
- Demonstrate sense of urgency; ability to recognize time sensitivity.
Pay Rate: $40-50/hr* Based on Experience
