Production Supervisor

Job Responsibilities

(Essential job functions noted *

  • Supervises day to day activity of the manufacturing, packaging and labeling of liquid pharmaceutical products*
  • Maintains cGMP quality compliance and regulatory compliance*
  • Establishes and meets productivity and production schedules*
  • Follows all established guidelines for accurate manufacturing reporting and employee records*
  • Troubleshoots process/production problems*
  • Aids in the investigation of any out-of-specification assay results*
  • Implements and develops operational strategies to optimize process, production and maintenance systems*
  • Ensures process control, product quality and overall efficiency of manufacturing, packaging and labeling*
  • Ensures plant safety and OSHA regulations are met*
  • Analyzes staffing needs and makes staffing adjustment recommendations accordingly*
  • Conduct performance reviews of direct reports*
  • Actively work on and trains staff on the scale up from R&D Laboratory Batch Formulations to Production Pilot Batches and full-scale Production Batches*
  • Participates in writing/reviewing and performance of IQ/OQ and PQ documentation for all production equipment
  • Participates in recommendation, acquisition and implementation of new production equipment and processes
  • Participates in writing/reviewing of Company SOP’s, relating directly to the production department
  • Precisely follows work orders and specifications*
  • Promotes a positive can-do attitude*
  • Collaborates in cross functional teams*
  • Consistently follows all company policies & procedures. *
  • Performs other duties as requested
  • Meets the following physical requirements:*
    • Sits, bends, stands, walks 90% of the time*
    • Repeatedly lifts or pushes a cart with 35-80 lbs*
    • Able to pass a respirator health test
    • Willing to wear required PPE

Qualifications – Education and Experience:

  • Prefer BS/BA degree in Engineering, Chemistry, Pharmaceutical Sciences or related field*
  • 5+ years of Supervisory experience in pharmaceutical or food manufacturing in compliance with 21CFR Part211—Current Manufacturing Practice
  • Strong understanding of cGMP guidelines and FDA regulations related to the pharmaceutical or food industry*
  • Proficient use of MS Office applications*
  • Must be high energy, extremely motivated, possess a strong leadership style with analytical and problem-solving skills, must be willing to work first or second shift and weekends if needed
  • Flexible and open minded to suggestions from others; keen vision for continuous improvement.*
  • Knowledge of Lean, 5S, Six Sigma and Kaizen continuous improvement concepts

This job description is subject to change at the sole discretion of Aurora Pharmaceutical, LLC.