Manufacturing Production Coordinator, B Shift

Manufacturing Production Coordinator, B Shift Who we are?

As a French pharmaceutical industrial group, we strive to make healthcare solutions that improve and simplify patients' lives accessible to as many people as possible.

As a world leader in sterile single dose, we have 10 sites on 4 continents and more than 2400 employees.

Since 2013, our site Unither Manufacturing LLC. based in Rochester (NY), specializes in the manufacture of Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules. It has more than 360 employees.

Reporting to the Shawn Estrich
,

This position has a direct impact on ensuring maximum up time for assigned lines and making sure production requirements are met. A key element of this position is ensuring Production employees are adequately qualified to perform their assigned job duties by validating they are appropriately trained in compliance with GMP requirements. The Production Coordinator will ensure that all safety hazards are identified and adequately controlled by monitoring employees’ compliance to procedure, safety, and GMP requirements.

When performance gaps are observed, the Production Coordinator will coach employees to improve their job performance. Production Coordinator’s will work closely with Production Management and Quality Assurance to execute production plans. May be required to function as Production Supervisor in their absence.

• Schedule Flow Maintained (20%) – Ensures work is allocated effectively, employees are at their assigned location; and checkpoints and controls are set for monitoring performance.
• Evaluates and communicates status of scheduled workflow with Production Supervisor at the start of each workday and throughout shift.
• Prepares for production by reviewing the production schedule, understanding deliverables, and reviewing applicable SOP’s, and any procedure changes.
• Ensures that supplies, materials and documents are available as required to meet the production schedule.
• Stops production and notifies QA and Production Supervisor immediately of any safety and quality concerns.
• Works with other departments to ensure adherence to production schedule.
• Receives and distributes supplies into production area, as necessary.
• Executes equipment qualification protocols and validation protocols.
• Ensures that Line and Plant conditions are acceptable for next run/shift. This may include manually cleaning portable equipment and small parts.
• Performs routine maintenance and cleaning of production equipment to maintain equipment in GMP fashion.
• Ensures equipment conditions are acceptable to pass to incoming shifts. Communicates any ongoing equipment, material or quality concerns to incoming teams as well as his/her supervisor.
• Ensures all paperwork is completed thoroughly and accurately prior to the end of the shift. This includes batch documentation as well as shift-to-shift communications, scheduling changes, SQDC reporting, ERP transactions, and deviation updates/support.

• Operates general production equipment ensuring its proper operation and adhering to production procedures.
• Monitors and records critical process parameters.
• Documents production by completing forms, reports, logs and records of equipment and batches.
• Keeps equipment operating by following operating instructions, troubleshooting breakdowns, and placing work orders for repairs.
• Provides input regarding opportunities for improvement, waste reduction, etc. to supervision and/or during team meetings.
• Recommends overtime to ensure production schedule requirements are met.

• Confirms that employee training is effective by conducting assessments that require participants to demonstrate mastery in a specific content area.
• Delivers one-on-one or group training to individuals on assigned processes that includes not only information on the process, but the opportunity to practice.
• Regularly follows up with trainees to provide any additional training after the release from training.
• Monitors the effectiveness of training efforts to identify…