Chemist C

QC Chemist C will perform a variety of QC testing to assess the strength, identity and purity of test samples and/or materials. Will work as a member of the stability team to effectively execute QC analytical testing using established (official and/or in-house) test procedures. This role will entail 80% - 100% of their work being performed at the bench level. The Chemist C will be responsible for review of analytical documents , investigations, maintain the GLP status in lab. Perform assigned in-process, finished product and stability product testing, using various wet chemicals, physical and instrumental techniques ( HPLC, UPLC, GC, UV-Vis, IR, Particle Size Analyzer, KF Auto titrator, Bulk Density, and other routine QC instruments) as per as per Finished Product methods. Independently plan and execute testing to meet established time-lines. Perform complicated testing with little supervisory direction. ssist with the preparation or review of Test Procedures, SOPs, Protocols, and CoAs as assigned. Record data and results as specified in documentation procedures. Document work clearly and perform tests accurately. Perform maintenance and calibrations of laboratory instruments/equipment with little supervisory direction/training. Perform troubleshooting and investigations under the direction of a supervisor. ssist in drafting deviation reports as assigned. Comply with all regulatory/in-house requirements (may include but not limited to safety, house keeping, laboratory chemical waste, cGMP, cGLP, documentation) when performing the assigned activity. Review of analytical documents Investigation for OOS/OOT/Deviation and other lab related events Knowledge of EMPOWER Chromatography Data System and LIMS QC experience in Generic Pharmaceutical industries would be preferable Experience in a cGMP environment is required Knowledge and use of Good Documentation practices Knowledge of USP/ICH/FDA guidelines Team player who will assist junior colleagues Willing to work flexible hours to meet product deliverables bility to learn quickly and have decision making skills that adhere to regulatory practices is required Perform other duties as assigned BS or MS in Chemistry or Pharmaceutical Sciences, or related field Minimum 5+ years of experience in Pharmaceuticals and Analytical testing is desirable Preference shall be given for experience in Inhalation testing on a variety of Inhalation products Integrated Resources