Quality Control Chemist
- Perform assigned sampling, physical, chemical tests and assay on raw materials, active pharmaceutical ingredients, in-process, finished and stability products, using various wet chemicals, physical and instrumental techniques (HPLC, GC, UV-Vis, IR, Particle Size Analyzer, NGI cascade impactor, KF Auto titrator, Bulk Density, and other routine QC instruments) as per as per USP monograph / In-house / any other Compendial monographs.
- Work with supervisor to plan and make adequate inventory of test reagents and solutions to perform work, assure supplies are ordered as needed to perform assigned work.
- Work with supervisor to plan and execute testing to meet established time lines. Perform complicated testing with supervisory direction.
- Record data and results as specified in documentation procedures. Document work clearly and perform tests accurately.
- Prepare and/or Review Test Procedures, SOPs, and Protocols as assigned.
- Perform maintenance and calibrations of laboratory instruments/equipment with supervisory direction/training as needed.
- Perform troubleshooting and investigations under the direction of a supervisor.
- 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 as required
- Perform other duties as assigned
- BS or MS in Chemistry, Pharmaceutical Sciences, or related field is preferable
- Minimum 5-10 years of experience in pharmaceuticals and must have 5 + years of experience in Analytical testing
- 5+ years QC experience in Generic Pharmaceutical industries would be preferable
- Experience in a cGMP environment is required
- Experience with dermatological, transdermal, and/or inhaled dosage forms is preferable
- Knowledge and use of Good Documentation practices
- Knowledge of USP/ICH/FDA guidelines
- Ability to learn quickly and having decision making skills