Summary: Conducts chemical and physical testing of pharmaceutical finished product and stability samples by internally developed and compendial test methods.
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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. xhqgsiq
- Strong attention to detail.
Quality Control Scientist in high point at Unknown Company
This position is listed as full time and onsite.