Fill Finish Operations Supervisor

This position is responsible for supervising a team of manufacturing technicians and Group Leader positions producing FDA licensed final products and contract manufacturing and clinical products under GMP compliant conditions as required to meet the production plan. This position will requiring working an evening shift.

ESSENTIALS OF THE JOB

• Oversee and participate in the aseptic filling, visual inspection, and finishing (final packaging and serialization) of IgG and other products produced according to cGMP guidelines.
• Act as the primary lead for technical issue troubleshooting including automation and mechanical issues on highly complex equipment including the Vanrx Robotic Workcell, Vial Labeler, and packaging and serialization equipment.
• Supervise Mfg Technician and Group Leader positions. Manage requests for time off. Prepare annual performance appraisals and recommend salary increases. Review and approve time cards to ensure compliance with attendance policy. Handle disciplinary measures for staff as well as promotion recommendations. . Interview and participate with other management members in hiring staff.
• Provide on the job training, technical training, assessment of progress and coaching. Work with trainers to assure development of proper work and documentation practices and identification of specific individual training needs for all team members.
• Maintain a clean, GMP compliant and safe working environment.
• Assure timely and accurate initiation and completion of quality system documents (Deviations, CAPAs, Change Controls, etc.) as assigned / required.
• Provide shift leadership and sound judgement and decision making regarding quality, processing, capacity, personnel, and any other issues as they arise with appropriate consultation with and notification to management.
• Take ownership of and responsibility for the area, facilities, equipment and processes during shifts. Assure facilities and equipment are operated, cleaned and maintained at a GMP compliant level.
• Prepare team and individual work schedules and coordinate assignments to maximize production efficiency while maintaining high quality and documentation standards . Coordinate personnel and resources on a day to day basis to accommodate the work schedule.
• Coordinate related work and scheduling with other departments including but not limited to Warehouse, Plasma Ops, QC,QA, PD, Eng Facilities, EHS, IT, Finance and HR.
• Must comprehend and understand automation systems, HMIs, etc. and possess mechanical aptitude to troubleshoot the type of problems associated with departmental processes and equipment.
• Prioritize work based on production schedule and meet deadlines.
• Assure that all appropriate logs and batch records are completed accurately and in a timely fashion per appropriate SOPs.
• Troubleshoot work related problems to ensure that delays are avoided whenever possible and issues are properly documented.
• Assure that raw materials that are needed for production are available in a timely manner so that adequate supplies are available to avoid production delays.
• Protect integrity and quality of product, elevating problems appropriately to management as needed to assure production decisions are made at the proper level.
• Be capable of reviewing both corporate policies and technical procedures, and successfully train and/or communicate pertinent information to subordinates.
• Assure all employees are in compliance with Standard Operation Procedures and meeting job descriptions, and policies and procedure requirements.