Supervisor, Manufacturing Operations (Compounding) 3rd Shift

The incumbent in this position is responsible for daily coordination and working schedules of people and equipment in Compounding Operations.
Responsible for Supervising Compounding and Support Technicians that prepare batches, compound drug products, while meeting department quality, safety, delivery, and productivity objectives.
Completes batch record documentation and manufacturing operations logs.
Ensures people and processes comply with safety requirements, current Good Manufacturing Practices, company policies and procedures.
Modifies department standard operating procedures, investigates variances, and executes change controls to support safety, quality and productivity objectives.
Responsibilities may include: Leads in development & maintenance of a safe manufacturing environment.
Participates in safety meetings, investigates accidents, and takes appropriate corrective action to eliminate hazardous conditions Runs operation to meet or exceed delivery performance objectives for product or projects Supervises staff in execution of daily work; assures operators comply with validated parameters and standard operating procedures, cGMP regulations and safety requirements; provides constructive operator feedback Counsels, trains, & develops technicians for efficient performance; creates an atmosphere of team effort & open communication Responsive to changes in daily workflow and schedule; determines needs & redeploys resources and/or overtime to achieve delivery & customer service commitments; adapts to ebb/flow of production process including changes due to absences, unplanned maintenance or events requiring investigation Completes in-process checks & verifications in alignment with Standard Operating Procedures Reviews documentation such as batch records and logs to assure accurate recording of processes in conformance to policies and procedures and in compliance with Good Documentation Practices Develops technician training programs & assures operator training is conducted Troubleshoots or resolves issues impeding daily/weekly deliverables; proactively demonstrates the ownership to achieve Initiates documentation of violations and disciplinary action with operators as required Understands & complies with employment standards Reviews operational performance and drives improvement opportunities Initiates & executes change control assignments in support of continuous improvement initiatives for equipment, documentation, or processes Drives Quality Management System assignments (CAPA, Deviation, Change Control, GMP tasks) to on-time closure Reports & initiates production schedule changes, requests equipment and facility repairs, or modifications Is consistently at work and on time; ensures work responsibilities are covered when absent and that absences are appropriately communicated and approved in advance Other duties as assigned Experience Required Well versed in the compliance & quality requirements of 503B pharmaceutical industry and CGMP's and have demonstrated strength in problem solving and resolution Experience training personnel on aseptic techniques and appropriate gowning techniques Successful completion of certified in-house qualification programs 1 year of supervisory or management experience required 2-3 years prior experience in cGMP / FDA regulated industry Legally authorized to work in the job posting country Preferred Bachelor’s Degree in Life Science or other related field preferred Education Required High School or better