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Position Title: Line Leader

Reporting: Production Supervisor

Location: Philadelphia, PA

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 year's experience in a production environment

Join us and be part of building the bridge between life changing therapies and patients.

Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.