Quality Control Scientist

Summary: Conducts chemical and physical testing of pharmaceutical finished product and stability samples by internally developed and compendial test methods.

Responsibilities:

• Utilizes validated test methods for pharmaceutical raw materials and finished products for strength, impurities, and identity, spectroscopy, and traditional quantitative analysis, spectroscopy, and/or traditional wet chemical testing as well as chromatography (HPLC and GC).
• Recognizes and reports out-of-specification or unexpected results and non-routine analytical and product problems; recommends solutions.
• Maintains and troubleshoots analytical instrumentation as needed.
• Clearly and accurately communicates the results of work by detailing of the testing/analysis and acquired results.
• Records and reports results of analysis in accordance with prescribed lab procedures and systems.
• Provides communications with outside departments.
• Cleans and organizes work area, instrumentation, and testing materials.
• Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines.
• Maintains the necessary compliance status required by company and facility standards.

Required Skills:

• Bachelor's degree in Science required, preferably in Chemistry or Biology.
• A minimum of 3 years chromatography experience with HPLC and GC.
• Experience with Empower 3 data acquisition software preferred.
• Experience in a GMP FDA regulated laboratory environment.
• Experience with common office software and chromatographic data acquisition systems.
• Strong communication skills (verbal and written).
• Good autonomous problem-solving skills.
• Strong attention to detail.