Senior Shift Supervisor, API Pilot Plant, Second Shift

Job Description
Supervise the operations, warehousing, and housekeeping personnel in the building during assigned shift. Work closely with the Technical Operations Support (Tech Ops) in planning production, evaluation of manufacturing capacity, and review of operational ability to perform process tasks. Work with Tech Ops and engineering to evaluate new/unique processes or unit operations and determine the requirements necessary to implement them in the plant.  Communicate status of production and manufacturing issues to staff, management, and support groups.  Assure staff meets all necessary training and certification requirements. Review direction sets prior to, during, and post manufacturing to identify potential issues and concerns. Initiate timely documentation of deviations/investigations of standard operations from compliance with quality, safety, and environmental events. Review and approve development modifications.
Ensures compliance with cGMP, GLP, OSHA, EPA, US Commerce, DEA, NSSD, DOT, and FDA/EU regulations.
Ensure that the Pilot Plant does not negatively impact clinical production status. Communicate production status and critical issues to operations, management, and support groups.  Participate in shift change over meetings at beginning/end of shifts when applicable.
Review and approve Process Safety Checklists prior to the start of a new process.
Initiate Near Miss, Op Notes, and incident investigations for failure to comply with required safety, quality, and environmental regulations.
Initiate, write and guide Development in writing development modifications.
Review direction set content before manufacturing begins to assure all documentation and processing requirements are accounted for. 
Review direction sets to verify that the RDL's and DDL's used for cleaning verification are the most current.
Perform and review of cleaning calculations required for equipment release from processing.
Review direction sets while in process to assure all necessary steps are being completed correctly and in a timely manner.
Review completed batch records before being sent to batch record review to identify/resolve issues.
Ensure design review and pre-run meetings are completed.  Ensure that shifts have an adequate number of trained staff for running processes.
Maintain and audit regulatory logbooks and documentation.
Work to resolve Corrective and Preventative Actions for quality metrics including calibration and Environmental Alerts.
Review and sign off equipment/facility/utility VCR/MOC packages.
Coordinate completion of utility/CNC+ (clean room) reinstatements.
Track labor and equipment utilization.
Provide timely feedback to employees on performance and areas of improvement.  Work with employees to identify resources for areas of improvement.