Job Summary
The position focuses on the coordination of release and stability testing procedures, thorough examination of laboratory data packages, and oversight of Good Manufacturing Practice (GMP) investigations and their associated documentation. Additionally, it encompasses the execution of non-GMP in-lab testing and management of external vendor interactions to guarantee adherence to regulatory standards.
Responsibilities
- Coordinate release and stability testing activities.
- Review laboratory data packets and documentation.
- Manage GMP investigations and maintain related records.
- Conduct non-GMP testing within the laboratory.
- Oversee external vendor functions to ensure regulatory compliance.
Qualifications
- Must possess a Bachelor’s or Master’s degree in Chemistry, Biochemistry, or a related discipline.
- A minimum of 1 to 6 years of experience in a GMP/QC environment.
- Demonstrated technical skills in analytical methodologies and data interpretation.
