Seeking a QC Data Review Scientist for our client – a leading contract development and manufacturing organization (CDMO). This is a great opportunity to contribute to the development and commercialization of innovative medicines, from early-stage development through final production.
Type: Direct Hire
Responsibilities:
- Identify technical problems, atypical results or methodology malfuctions and assist in the investiagation to correct them.
- Provide technical support for routine testing activities while conducting analyses of samples, products, and materials.
- Accurately generate data using validated test methods and SOPs in cGMP environment.
- Demonstrate technical competence in the use of wet chemical techniques and instrumentation: Infrared Spectroscopy, Ultra Violet/Visible Spectroscopy, Gas Chromatography, High Pressure Liquid Chromatography, Ultra High Pressure Liquid Chromatography, Atomic Absorption Spectroscopy, Dissolution apparatus, Compendial testing (USP, EP, JP).
- Initiates proper documentation upon discovery of deviations and out of specification results, completes Trackwise write-up for deviations and out of specification results.
- Performs special projects as assigned including testing, compiling, and trending of data and report generation.
- Works with vendors for instrument maintenance or upkeep.
- Understand and execute protocols and provide information to qualify and draft in-house test standards and methods.
- Revise SOPs and methods as needed.
- Performs instrument and method related troubleshooting and investigative testing.
- Responsible for analyzing data, maintaining accurate and detailed written records and notebooks and thorough review of lab notebooks to ensure compliance to test methods and specifications.
- Maintain training logs to comply with current SOP requirements.
Qualifications:
- Bachelor of science degree in chemistry, biology, or related science required.
- 2-5 years of experience in a cGMP analytical laboratory