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Job Description
Contract Length: 6+ months
Job Summary: This person will assist lab management in OOS/OOT/OOE/LE investigation, troubleshooting methodologies, providing corrective actions and preventive actions (CAPAs), and SME training for the department. This role is assigned to the 3rd shift from Wednesday to Saturday (4 x 10 hrs., 10 pm to 8 am).
Responsibilities:
Job Summary: This person will assist lab management in OOS/OOT/OOE/LE investigation, troubleshooting methodologies, providing corrective actions and preventive actions (CAPAs), and SME training for the department. This role is assigned to the 3rd shift from Wednesday to Saturday (4 x 10 hrs., 10 pm to 8 am).
Responsibilities:
- Perform QC analytical chemistry testing including, but not limited to HPLC, UPLC, GC, UV, CE, Particle Count analysis, and Dynamic Light Scattering, KF, Osmolality, Digestion, etc,
- Ensure the analytical testing and laboratory documentation meet cGMP and GDP requirements.
- Perform raw material, in-process (STAT), finished product and stability sample analysis when needed.
- Support method validation/transfers and special projects as assigned
- Ensure stability testing completed within the required timeline.
- Perform troubleshooting methods and equipment
- Actively support OOS, OOT, OOE, QE and LE investigations and be able to write investigation reports.
- Bachelor’s degree in a relevant scientific discipline, preferred in Analytical Chemistry, or Chemistry
- 5 years in a laboratory setting with focus in analytical chemistry
- Strong mathematical skills, including the ability to analyze scientific and test data, and solid understanding of statistical analysis
- Have in-depth knowledge of Analytical Chemistry theory (especially chromatographic separations by HPLC) and the operation of analytical laboratory equipment
- Have in-depth knowledge of analytical chemistry related to the SOPs and testing methods, especially for chromatographic separations using UPLC/HPLC/GC and the operation of general analytical laboratory equipment
- In-depth knowledge and expertise in method transfers/qualifications/validations
- Solid knowledge on cGMP, USP/EP/JP compendia testing requirements
- Solid knowledge of lab safety
- Highly proficient use of Microsoft Word and Excel, Chromatographic Software
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