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Quality Control Specialist
4 weeks ago
Quality Control Specialist - Microbiology
Proclinical Staffing is seeking a Quality Control Specialist to support quality control testing operations in a pharmaceutical environment.
Key Responsibilities:
This role involves conducting daily cGMP quality control laboratory microbiological testing activities, including in-process and final drug product microbial testing.
Requirements:
- Bachelor's degree in a relevant discipline (biological sciences or equivalent).
- Prior experience in a Quality Control role within the pharmaceutical industry.
- Experience with cell therapy products is a plus.
- Ability to interface successfully with multi-disciplined teams.
- Extremely detail-oriented with strong technical skills.
The Quality Control Specialist will:
- Conduct daily cGMP quality control laboratory microbiological testing activities.
- Perform environmental monitoring of cleanroom areas as per schedule.
- Analyze data and report results of microbiology assays to support product lot release, ensuring adherence to turnaround times.
- Maintain cGMP compliance in all activities.
- Conduct thorough cGMP investigations for out-of-specification test results.
- Perform environmental monitoring data trending.
- Assist in technical problem solving.
- Support product stability programs, including execution of stability testing, stability data analysis, and final reporting of stability data.
- Consistently operate at a high level of efficiency, producing high quality and accurate results.
