The Bulk Operations Supervisor will manage the Bulk Operations process at the shift level. They will work a continuous work week schedule as required by production demands, and will have the supervisory responsibility for the Bulk Operations personnel on the shift. They will be responsible for ensuring that the process complies with all cGMP and validation requirements at all times, which includes the control of all environmental factors. They will work closely with Process Control resources to ensure that all product quality targets are met and that all process issues are appropriately reported, investigated, and corrected.

Responsibilities:

• Ensure that all products consistently meet TRC quality standards and that the process operates in a state of control
• Ensuring the production schedule for the shift is appropriately communicated and understood
• Reporting execution variances to the production schedule
• Identifying areas for improvement in the execution of the schedule
• Assisting with the development of communication tools to improve the overall process
• Communicating any emergency changes to the schedule that come from the plant leadership team
• Ensuring that the Resin Room and Resin Silos are operating as required
• Ensuring that downtime information is entered into the downtime database as required
• Ensuring the departmental review of Batch Records is performed as required
• Involvement in continuous improvement projects
• Revise or develop SOP’s as required
• Support all TRC and departmental goals
• Maintain material inventories in the ERP system as required
• Ensure that team members’ training is completed as required
• Ensure that the plant utilities equipment is operating as needed
• Manage safety incidents per appropriate SOP’s
• Communicate departmental goals/expectations as well as individual goals to all team members
• Provide coaching/counseling to team members as necessary
• Conduct employee performance evaluations annually at a minimum
• Support the proactive maintenance effort by ensuring that maintenance work requests are written into the computerized maintenance management system
• Communicate openly with all areas of the plant
• Ensure that the change control process is followed as required
• Support validation activities as needed
• Notify appropriate personnel when relevant situations arise that require additional support

Qualifications:

• Technical degree or equivalent work experience
• Experience in a cGMP environment
• Minimum of 5 years experience in manufacturing
• Ability to handle and establish multiple priorities and meet expectations with minimal supervision
• Ability to work within a team oriented operation
• Able to use Microsoft Office and other Windows based software
• Strong oral and written communication skills