Job Description
The QC Chemist is responsible for performing routine and non-routine analytical chemistry assays of raw materials, in-process samples, finished formulations, stability samples, and for special projects, method development/transfers, and cleaning study qualifications. ● Performance of analytical testing for incoming, in-process, and final products, and stability samples. ● Performance of raw material monograph testing, as needed. ● Performance of wet chemistry assays. ● Performance of weekly water sample analysis for support of manufacturing. ● Performance of routine cleaning sample analysis for support of manufacturing. ● Performance of QC general laboratory equipment maintenance. ● Performance of QC method qualifications, transfers, and validations. ● Performance of QC method development. ● Backup for review of QC data. ● Assist QC Management, as needed, in the completion of OOS/departure investigations for QC.
Requirements
● Bachelor's degree in Chemistry or equivalent in a scientific discipline required. ● At least two years of experience working in a pharmaceutical laboratory. ● Strong knowledge of cGMP, FDA regulations, and ICH guidelines of USP, Pharm. Eur. and other compendial methods and procedures. ● Strong knowledge of analytical chemistry principles and techniques using various laboratory apparatus and instrumentation (i.e. UV/Visible Spectrophotometer, FTIR, TOC, pH meter, Karl Fischer Titrator, TGA, and DSC systems). ● Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, MS Project, etc.). ● Strong interpersonal and communication skills. ● Effective organizational and time management skills with the ability to multi-task and prioritize assignments as needed. ● Ability to work effectively under pressure in a rapidly changing environment.
Employment Type
- Full Time
Job Category
Seniority
Details
Employment type
- Full Time
Job Category
Educations
Seniority
