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Production Supervisor, Manufacturing Operations

2 months ago

Chantilly, Virginia, United States Granules Pharmaceuticals Full time
Job Summary

The Production Supervisor, Manufacturing Operations is responsible for the daily coordination and execution of working schedules of people and equipment in the Production line. This role requires a high level of knowledge in cGMPs and good manufacturing practices, as well as excellent communication, teaching, and leadership skills.

Key Responsibilities
  • Oversee hourly operators in the execution of daily work, ensuring compliance with validated parameters and standard operating procedures.
  • Develop and manage daily/weekly department work schedules, set priorities, and verify availability of resources.
  • Responsible for schedule adherence and participates in scheduling meetings to increase resource utilization.
  • Responsive to changes in daily workflow and schedule, determining needs and redeploying resources and/or overtime to achieve delivery and customer service commitments.
  • Ensure all equipment is working properly and maintain a safe work environment.
  • Reviews batch records and supporting records prior to submission to Quality.
Compliance and Quality
  • Understand and adhere to good documentation practices (GDP) and execute Quality Management System assignments (CAPA, Deviation, Change Control, Standard Operating Procedures etc.) to on-time closure.
  • Obtain knowledge and execute assignments in QMS areas: deviation management and/or change control.
  • Conduct investigations for cause, determine corrective action, and impact; write reports and assure timely closure.
  • Initiate and execute change control assignments in support of continuous improvement initiatives for equipment, documentation, or processes.
  • Initiate work orders for equipment repairs or modifications.
  • Create, review, and conduct operator training programs and assure operator training is conducted on SOPs, cGMP, and safety.
Supervisory and Leadership
  • Reports production updates and schedule changes to team and/or at daily meetings.
  • Assure hourly operators comply with all procedures, GMP regulations, safety, and contract obligations; provide constructive operator feedback.
  • Assign manpower; initiate documentation of violations and disciplinary action with operators as required.
  • Request equipment and facility repairs, or modifications.
  • Understand and comply with Union Agreement.
  • Keep manager informed of operations; elevate as needed.
Requirements
  • Minimum Education: B.A./B.S. Degree in Science, Business or related field or significant experience.
  • Minimum Experience: 5+ years in a supervisory role within Pharmaceutical Manufacturing, Operations, or Quality Department with increasing levels of responsibility or equivalent.
  • Knowledge: Knowledge of Quality MS (Management Systems), Document MS, and MS Office Suite.