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.
Bachelor's degree in Chemistry or equivalent in scientific discipline required.
At least two years of experience working in 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, 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.