Job Description
Performs incoming raw material and packaging testing utilizing analytically procedures including USP, EP, BP, JP, ACS and Sanofi Pasteur internal work instructions. All work is performed in accordance with cGMP guidelines along with Sanofi Pasteur internal policies and procedures.
This position requires the individual to work with trained quality analysts in the performance of routine testing in support of multiple platforms of Sanofi Pasteur production, vendor qualification and method verification by performing the following tasks:
1. Assists with maintaining safety and compliance of the laboratory work area.
2. Performs cGMP cleaning of the laboratories, equipment, and ancillary areas as required, in preparation of assay performance for release of compendial testing.
3. Acknowledgment and understanding of compendial procedures, clarification and agreement for following instructions both verbal and written.
4. Perform routine analytical testing.
5. Preparation of container closure materials for testing.
6. All other duties as assigned
Qualifications
· Ability to work in a dynamic team environment.
· Basic Qualifications: BS in Chemistry, Biochemistry or related field.
· Experience in a cGMP environment.
· Laboratory skills and knowledge of analytical chemistry testing.
· Preferred Qualifications: Experience in a Quality Control Organization within the Pharmaceutical/Biotech industry and compendial testing.