Somerset, New Jersey
14 days ago
Review all analytical reports and raw and electronic data from QC, including: raw materials, finished products, stability study samples, packaging materials, in process materials, cleaning analysis, and equipment calibration. Inform QC Manager when tests are not within specified limits to take appropriate actions.
- Perform review of all tests results, raw data including electronic data generated in support of testing of raw materials, in-process, finished product and stability samples including dissolution, assays, chromatographic purity, content uniformity using UV and HPLC, particle size distribution using different techniques including Light Scattering (e.g. Malvern), density, water determination by KF, and tests according to the in-house monographs and USP in a regulated laboratory environment.
- Review all validation and method optimization reports.
- Ensure chemists follow all SOPs and cGMP regulations and use the correct method or procedure for each product.
- Ensure notebooks are reviewed in a timely manner, in accordance with SOPs. Sign off on all analytical test results and reports.
- Analyze and interpret results in written and oral format.
- Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment and Safety Practices.
- Bachelor’s degree in Chemistry or related field
- 4+ years related experience in pharmaceutical analysis
- Previous experience using all types of analytical instrumentation, software, and tests performed in the lab, including:
HPLC, GC, Dissolution, Raw Materials, etc. is required.
- Understanding of SOPs, USP/NF procedures and requirements.
- Previous cGMP/regulatory experience is preferred