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Director of Quality Control and Stability
1 month ago
We are seeking a highly experienced Director of Quality Control and Stability to join our team at Hyper Recruitment Solutions. As a key member of our organization, you will be responsible for overseeing the development and implementation of a compliant stability program, ensuring all data reports and documentation are available on schedule.
Key Responsibilities:
- Oversee routine and non-routine stability studies, ensuring all data reports and documentation are available on schedule.
- Manage and maintain a compliant stability program, including sample management, identifying stability studies, authoring stability protocols and reports, and maintaining trending of all stability activities.
- Provide technical expertise for laboratory investigations, troubleshooting assays, and ensuring acceptably low invalid rates.
- Lead the QC Stability team, including recruitment, leadership, and direction, as well as managing external vendors and contract testing facilities.
Requirements:
- Relevant degree in Chemistry, Biochemistry, Microbiology, or a related science.
- Extensive industry experience in a GLP/GMP-regulated environment, with a focus on laboratory-based testing and management.
- A working knowledge and practical experience with stability testing, regulatory submissions, and continuous improvement processes.