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Operations Supervisor

Frazer, PA 19355

Posted: 03/22/2023 Employment Type: Contract Job Category: Operations Job Number: 546493 Is job remote?: No Country: United States

Job Description

Pay rate range: $38-40/hr

MUST have a degree and Must have GMP and Pharma Production experience. 3+ years administrative leading a team. Two years’ experience in a direct GMP manufacturing setting with demonstrated leadership skills Micronization Experience is a plus but not required. Education: Bachelor’s degree or higher 4-6 years in a regulated environment.
Micronization Experience is a plus but not required.
The Operations Supervisor is responsible for supervising site manufacturing operations, ensuring that all work completed is within timeframes /standards, holding self and team accountable for:
  • Safety - Adherence to CMTI and industry safety standards. Serve as safety role model.
  • Quality/Compliance - Adherence to CMTI Quality systems/cGMP
  • Delivery - ensuring a timely flow and completion of micronization and milling jobs
  • Cost - Ensure base cost and inventory management, process efficiency and resource utilization.
  • People - Accomplish the sites goals work through themselves as well as through others while consistently modeling Catalent values and leadership competencies in all interactions.
II. Specific Activities, and Responsibilities Operations
  • Directs production operators engaged in manufacturing activities by defining priorities, daily expectations and assignments ensuring a timely flow and completion of micronization and milling jobs
  • Performs routine GEMBA on shop floor to ensure GMP & GDP adherence
  • Communicates issues to the appropriate parties, shift status/transition issues to the following shift and cascading office/operations communications to staff as requested
  • Technical review of BMRs, providing coaching and feedback to operators to achieve FIRST TIME RIGHT
  • Ensures and validates the cleaning of the entire processing area and processing equipment
  • Acts as a liaison between management and operators by effective communication/dissemination of information.
  • Conducts manufacturing deviation investigations in trackwise
  • Performs process operator duties when required
  • Suggests process improvements to enhance efficiency and quality
  • Participate in client audits and visits when requested.
  • Demonstrates the ability to troubleshoot and perform basic repairs of systems and equipment
  • Participates in the establishing/updating of Standard Operating Procedures (SOP).
  • Completes special projects as assigned by the Operations Manager
  • Perform Shop Floor inspection/check on going processing
  • Willing and able to work weekends as needed
Staff Management
  • Provides feedback and holds operations staff accountable
  • Responsible for the on-time and thorough completion of all operator training requirements.
  • Coaches staff on BMR completion with the goal as first time right
  • Assist in operator selection/retention.
  • Maintain positive employee relations.
  • Maintains documentation on employee performance.
  • Composes and delivers operator performance reviews.
  • Administers employee discipline as required.
  • Assist operators with quality resolution/improvement.
  • Work with on floor QA support for any quality resolution
  • Document Atypical Even in real time and initiate deviation within 24HR in Trackwise
  • Ensures that product quality meets predetermined specification.
  • Work with labs to ensure priority on sample testing
Scheduling and Reporting
  • Able to adjust to a changing production schedule.
  • Ensures On Time Delivery.
  • Submits data for production metrics.
Physical Requirements:
  • Ability to stand or walk for up to 8 hours per day.
  • Ability to climb steps and ladders.
  • Ability to lift up to 44 pounds as needed.
  • Ability to wear a respirator and pass the required respiratory medical clearance.
  • Ability to wear safety shoes when applicable.

Skills Requirements: Very good organizational skills
Computer - Email, Workday, Oracle.
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