RXD Operator III

GENERAL PURPOSE

The primary purpose of this position is to manufacture RxD dispersions at the COUS site. The Production Operator is responsible for performing all manufacturing activities within all EHS, quality, and corporate guidelines on a right-first-time basis. The operator is independently responsible for manufacturing activities and priorities, following all appropriate training programs, complying with all documentation within the department (i.e. SOP’s, process logs), and effectively communicating with other operators as well as supervision and other departments.

In addition, the Production Operator will perform routine manufacturing cleanouts and equipment changeovers, monitor in process and post batch data, and operate the process control systems to effectively run the plant.

• Safely operate the production unit in compliance with site, company and regulatory requirements.
• Effectively work with the rest of the manufacturing team to deliver business objectives and targets.
• Monitor operational performance to maintain or improve quality, cost and productivity.
• Routinely participate in Continuous Improvement and particularly 5S in normal operations practices. Ensure personal compliance with all training and support other members of the team in doing so.
• Follow Standard Operating Procedures and help keep them up to date and accurate through effectively communicating operator comments and input.
• Follow the company’s adopted Quality, Safety and Environmental management systems and procedures.

• Demonstrate a high regard for your own personal safety and the safety of others.
• Ensure full compliance with all EHS procedures and policies to deliver compliance with regulatory and site requirements. Follow procedures to ensure compliance with hazard study controls.
• Be responsible for individual and team safety performance. Understand key performance indicators (KPIs) and respond to anything that requires action.
• Log and participate in investigating any near misses or incidents to support identifying root cause and opportunities for improvement working within established systems.
• Ensure compliance with ISO 14001.
• It is strongly encouraged to be trained as Emergency Coordinator / Contact onsite to handle emergency situations (injuries, spills, fires, etc).

• Be flexible and responsive to help ensure sufficient level of resource is in place at all times to deliver required production.
• Stay fully trained and validated in all areas of operations. Follow defined training paths and take initiative to seek additional training.
• Participate as needed during plant outages to accomplish production maintenance tasks, PM’s and projects.
• Identify and communicate daily plant maintenance needs to maintain a safe, efficient operation by submitting work orders as needed for repairs and maintenance.
• Participate in the Continuous Improvement program to bring forward suggestions to improve and optimize the production process.
• Follow the production schedule to deliver on time and in full product in a right first time manner.

• Participate in the investigation of any quality near misses or failures, identifying root cause and opportunities for improvement. Implement follow up actions as required.
• Assist in review of technical issues, contributing where possible to improve overall performance of processes and plant. Especially contribute manufacturing observations that may be relevant to troubleshooting, identifying root causes, and solving problems.
• Manufacture to high standards to ensure customer product requirements are achieved and Customer Satisfaction is maintained.
• Follow procedures and pay attention to detail to provide error-free operation and batch production.
• Ensure compliance with ISO 9001 and all site QA policies.
• Maintain compliance with GMP manufacturing policies.

• Report any issues with unit equipment to key functions for action to help maintain efficient operation.
• Understand key manufacturing costs to help stay within Cost Center budgets.
• Actively identify opportunities to improve plant…