QC Chemist II, QC
Essential Duties and Job Functions:
- Executes biochemical and chemistry release and stability testing using CE-SDS and icIEF following written procedures and applicable SOPs. Reports data in a GMP compliant manner.
- Supports in-process, release, and stability testing using routine analytical techniques such as capillary electrophoresis, as well as concentration analysis by A280 as needed, based on laboratory demand.
- Participates in validation and technical transfer of analytical methods commensurate with experience.
- Performs timely and accurate peer review of analytical test results.
- Performs preventative maintenance and/or calibration activities or coordinates and schedules these activities with a third-party provider.
- Responsible for cleanliness and orderliness of work area, maintains the laboratory in a state of inspection readiness and performs other laboratory maintenance duties as assigned.
- Participates in continuous improvement initiatives; looks for ways to improve compliance or efficiency and communicates to management.
- Participates in laboratory investigations and root cause assessment.
Essential Education, Experience and Skills:
- Bachelor's Degree and a minimum of 3 years of applicable GMP laboratory experience is required.
- Experience using analytical techniques such as capillary electrophoresis and UV spectrophotometry.
- Ability to exercise independent judgment in developing methods, techniques, and evaluation criteria for obtaining results.
- Excellent oral and written communication, organizational, and interpersonal skills with ability to multitask while working under restrictive timelines.
- Ability to work in a team environment and perform job responsibilities with minimal supervision.
- Knowledge with analytical methods currently used for purity and impurities testing for release and stability of biopharmaceutical products.
- Fluency in Empower, Windows, and Microsoft Office.
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