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Production Supervisor

Fresenius Kabi USA

Wilson, NCOnsitePosted 31 days ago$73,614 - $103,528
Full TimeSenior LevelManufacturing & CMCPharmaceutical
Original posting ↗

Summary

Responsible for the supervision and coordination of production personnel and processes within an assigned area of responsibility. Provides oversight to ensure a safe, effective and efficient operation of manufacturing equipment, ensuring conformance to all quality standards, applicable SOP's and cGMP's and compliance with all company requirements. Has a thorough understanding of equipment operation, batch record requirements and reviews all documentation during production and batch reconciliation.

Job description

Job Summary

Responsible for the supervision and coordination of production personnel and processes within an assigned area of responsibility. Provides oversight to ensure a safe, effective and efficient operation of manufacturing equipment, ensuring conformance to all quality standards, applicable SOP's and cGMP's and compliance with all company requirements. Has a thorough understanding of equipment operation, batch record requirements and reviews all documentation during production and batch reconciliation.

Responsibilities

  • Coordinates the execution of the production schedule and equipment changeovers based upon direction from the production managers. Oversees the production processes on their assigned shift, across multiple manufacturing lines, working on the production floor to coordinate all relevant production activities and supervise hourly production employees.
  • Interacts with supervisors, managers and support groups to maintain compliance with procedures, standards, policies and cGMP's.
  • Coordinates batch related documentation including, data entry, verification, review and approval as required.
  • Assumes responsibility for production personnel, production metrics, equipment condition and facility condition.
  • Assures the compliant application of departmental and company policies and procedures, safety programs, standards and cGMP's.
  • Completes thorough deviation investigations timely, performing detailed root cause analysis and implementing corrective and preventative actions.
  • Writes Investigation reports and mitigation plans as required.
  • Monitors and controls production schedules and activities to ensure departmental performance objectives and budgets are met.
  • Update and enhance departmental SOP's.
  • Recommends and implements value and process improvement programs.
  • Coordinates staffing for their assigned area of responsibility and assures personnel training is up to date. Develops and executes training and follow-up programs to enhance staff development. Regularly evaluates performance of operations personnel.
  • Establishes effective communication methods to provide continuity of information across all operations and shifts.
  • Empowers assigned personnel to engage in defining and recommending continuous process improvements.
  • Contributes to development of annual departmental operating budget.
  • Provides a daily update on performance.
  • Assume other duties and responsibilities as assigned.

Requirements

  • Thorough understanding of manufacturing equipment operation
  • Thorough understanding of batch record requirements
  • Thorough understanding of quality standards
  • Ability to lead production personnel
  • Ability to implement process improvements within a regulated environment
  • Knowledge of cGMP compliance
  • Knowledge of SOP management
  • Experience with deviation investigation and root cause analysis

Benefits

  • 401(k) plan
  • Paid vacation
  • Holiday days
  • Personal days
  • Employee assistance program
  • Medical insurance
  • Prescription drug coverage
  • Dental insurance
  • Vision coverage
  • Life insurance
  • Disability insurance
  • Wellness program

Company overview

Fresenius Kabi USA is a leading global healthcare company and a subsidiary of Fresenius Kabi AG, specializing in pharmaceutical manufacturing and medical technologies. Headquartered in Lake Zurich, Illinois, the company operates as a comprehensive provider of essential medicines and technologies for critically and chronically ill patients. With over 43,000 employees globally and a presence in more than 100 countries, Fresenius Kabi USA focuses on four complementary business areas: Biopharma (biosimilars for autoimmune diseases and oncology), Pharma (IV drugs and infusion therapy), Medical Nutrition, and MedTech. The company's extensive portfolio includes injectable drugs, delivery systems, advanced transfusion medicine, cell therapy technologies, clinical nutrition products, and infusion devices. Serving hospitals, long-term care facilities, alternate care sites, and clinics, Fresenius Kabi USA is committed to providing high-quality, lifesaving medicines and technologies while driving healthcare transformation through innovation and patient-centric solutions.

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