Line Leader - 3rd Shift - PCI Pharma Services

Essential Functions: Line Leader

* 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.

POSITION REQUIREMENTS:


* Must possess and demonstrate leadership qualities and be a motivator of people.

* Must be dependable and show initiative to improve the overall production process.

* Must be detail and quality oriented.

* Must possess and demonstrate average verbal, written and interpersonal communications skills.

* Must possess average mathematical skills.

* Must work well under pressure.

* Must be able to interact effectively with a variety of individuals and personalities within and between departments.

* Must possess and demonstrate knowledge and experience in cGMPs.
Reports to:

* Production Supervisor
Supervises:

* Line personnel
Education:

* High school diploma or equivalent
Experience or Equivalent:

* 2+years' experience in a production environment
Equal Opportunity Employer/Vet/Disabled