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Now viewing: Quality Control Chemist - I*
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Quality Control Chemist - I*
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Responsibilities (include but are not limited to):
- Perform testing of raw materials, intermediates and final products by following analytical methods: Cell based bioassays, Flow Cytometry, ELISA and qPCR assays.
- Work with internal and external resources to maintain lab in an optimal state.
- Assist with monitoring and trending data, complete routine record review of test data and related documents for in-process testing, drug substance and drug product release Supply information to support generation of CoAs for product release.
- Maintains laboratory instruments for calibration and routine maintenance
- Author or revise SOPs, qualification/validation protocols and reports.
- Asist with lab investigations regarding out of specifications (OOS) results Participate in determination of root cause for deviations related to analytical procedures
- Provide updates at daily and weekly meetings.
- Monitor the GMP systems currently in place to ensure compliance with documented policies.
Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate. - Gather metric information for use in continuous improvement of areas of responsibility.
- Perform other duties as required.