Location: all cities,PA, USA
Red Lion Road-PA002
Leads the operations and activities of the production team within the room to ensure that throughput is maximized, while sustaining safety, quality, and timeliness.
SPECIFIC DUTIES, ACTIVITIES, AND RESPONSIBILITIES:
Pre-production responsibilities & activities:
* Reads and reviews the MPI's, relevant SOPs, and the shop floor packet prior to job start-up, to identify and understand all production, validation, and/or special requirements (e.g., temperature, humidity, etc.).
* Determines the placement of personnel on the production line, according to quality critical skill sets required at each line station.
* Verifies line clearance and completes required Line Clearance and Use Begin forms prior to start-up.
* Checks all incoming components against the batch record to verify that they are correct.
* Documents receipts in the batch record.
* Fills out In-Process and Reject labels prior to job start-up.
* Reads MPI's and other production requirements to the room crew prior to job start-up, ensuring that all personnel thoroughly understand the quality and process requirements of their assigned position.
* Ensures that all line personnel sign the required sections of the batch record and training sheets, and initial their assigned station on the line diagram.
* Perform start-up and in-process quality inspections, testing and sampling.
* Perform periodic reviews of the batch record throughout the production operation to ensure cGMP compliance and completion and accuracy of the appropriate pages.
* Notify QA and Production Supervisor when tests and/or inspections do not pass
* Verify all coded information (lot number and expiration date) are set correctly throughout the packaging line, and completes all qualified challenges on a production line.
* Ensure that equipment calibration dates in preproduction rooms are within required specifications and contacts appropriate personnel to recalibrate as required.
Ongoing responsibilities & activities:
* Ensures that all operations and personnel within the room are trained and in strict compliance with the MPIs and applicable safety and quality procedures and regulations.
* Ensures that all packaging strictly conforms to MPI and PCI specifications.
* Ensures that the room remains clean throughout the production run.
* Documents, monitors and helps control Constraint Downtime and Buffer Management within the room so as to maximize throughput.
* Ensures that mechanical and production resources, machine speeds and productivity are in accordance with the quantities and rates estimated for the job.
* Identifies the constraint and manages the buffer (according to the Management of the Buffer in the Production Room Guidelines).
* Monitors material and waste quantities and communicates additional material needs to the Production Supervisor.
* Provides production status updates to the Production Supervisor on a regular basis throughout the shift.
* Reports all paperwork issues and discrepancies and material delays to the Production Supervisor for resolution.
* Ensures that room cleanliness is maintained throughout the production run.
* Reports any violation of company and/or safety policies, cGMPs, and the Collective Bargaining Agreement to the Production Supervisor for action.
Post-production activities & responsibilities:
* Reviews batch record and reconcile all materials at the end of production.
* Completes the required sections of the batch record in accordance with cGMP regulations.