Job description
Responsibilities
:
- Associate II (contractor) with cGMP quality control analytical testing experiences. The individual in this role will perform in process, release, and stability testing in quality control Chemistry laboratory. Also, this individual may support special projects as assigned.
- Work on in-process, release, and stability testing for raw materials, drug substance, intermediates, and drug products in accordance with cGMP, SOP, FDA, ICH, and other regulatory requirements.
- Routinely use analytical equipment including, but not limited to HPLC, UPLC, LC-MS, GC, UV plate reader, particulate matter, particle size analysis with Dynamic Light Scattering, KF, Osmolality, etc.
- Follow current test methods and/or protocols to perform analytical testing.
- Document the testing procedure and results using Assay Performance Worksheets and/or LIMS as per GDP requirements and submit data packets for review.
- Maintain compliance to data integrity and cGMP in QC lab in line FDA and ICH guidance.
- Performs general laboratory support activities including reagent preparation, sample management, equipment maintenance, lab housekeeping and 5S activities, etc.
- May assist with troubleshooting of assay methods and equipment.
- Involve in lab event (LE), OOS, OOT, OOE, and deviation investigations.
- May implement CAPAs and perform effectiveness check..
- Complete on job training activities.
- Involve in supply management to ensure there are sufficient reference standard, reagents, supplies prior to your testing.
- Review/write/revise SOPs, protocols, and reports.
- Establish and maintain a safe laboratory working environment.
- 3 years of hands-on experience with HPLC and UV instrumentation and chromatographic software.
- 3 years of general laboratory operations (Micropipette and analytical balance use, pH, reagent preparation, centrifuge, etc.).
- Strong technical writing ability.
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