Evaluate and implement new analytical technologies, , computer systems, software, HPLC and GC data systems, instrumentation, and updated compendia methodologies
Assure lab equipment is qualified, calibrated and within PM program
Responsible for identifying, alerting and proposing solutions to issues on instruments and/or test executions
Oversees all in-process and release activities for buffers, intermediates, and finished drug product
Responsible for all applicable QAD input associated with release of finished goods
Coordinates QC functions with operation activities and cross departmental staff
Participate as a member of the lab safety committee
Ensures implementation and maintenance of quality systems, including but not limited to, SOP writing, deviations, technical report review and personnel training
Work with Quality Systems to develop testing plans for new devices as requested
Manage team to include interviewing, hiring, performance management, and goal setting
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