Job Description
Job Description
- 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