Job Overview
Performs Analytical chemistry examination testing on raw materials, finished products or stability samples in accordance with approved Standard Operating Procedures (SOPs) and valid methods
Reporting Structure
Reports to QC Manager
Key Roles/Responsibilities
- Chemical or Physical testing analysis of raw materials, finished products, stability or request samples
- Documenting and submitting all raw data and results in LIMS
- Preparation of reagents for chemical analysis including peer review
- Knowledgeable in compendial (USP/EU) testing requirements and ensuring compliance per FDA 21 CFR
Experience
- Bachelor's degree in chemistry, biology, microbiology or other related science with relevant laboratory coursework is required.
- 0 - 2 years laboratory experience, preferably in a GMP environment
Competencies
- Basic knowledge of laboratory safety practices and PPE
- Basic knowledge of cGMP
- Basic understanding of good documentation practices
- Understanding of compendial testing requirements
- Preferred experience with FTIR, dissolution, UV-VIS, Karl Fischer, pH, wet chemistry techniques, reagent preparation, volumetric solutions.