About The Position

The Supervisor, Pharmaceutical Coating oversees production staff and operations to ensure assignments are completed on schedule, production targets and quality standards are met, and established policies, procedures, safety rules, and cGMP requirements are followed. The role monitors equipment, production output, work areas, documentation, and inventories; supports investigations and corrective actions; and coordinates with Production management and departments including Quality Assurance, Maintenance, and Engineering. The supervisor also trains personnel, reviews production records, coordinates procedural revisions and training, and supports process development, scale-up, validation, equipment qualification, and the transfer of new products and processes into commercial operations. This role is assigned to 5th Shift and is eligible for a 20% shift differential. Compensation may vary based on skills, experience, and location; the stated salary range is $30,000–$49,000 USD.

Requirements

  • Bachelor of Science degree or equivalent; a combination of education and/or experience will be considered.
  • 2–4 years of relevant experience.

Responsibilities

  • Ensure assignments are completed on schedule and according to established policies and procedures.
  • Guide and direct production staff to support compliance with the production schedule.
  • Monitor production output and line quality against standards, and initiate corrective actions with Production management, Quality Assurance, Maintenance, Engineering, and other relevant groups.
  • Monitor equipment operation and ensure safety rules and guidelines are followed.
  • Maintain clean and orderly work areas in compliance with cGMP requirements.
  • Prepare and approve rooms and equipment for inspection, and perform room releases as necessary.
  • Ensure equipment and room logs are current and accurate.
  • Coordinate and oversee operators in other areas as necessary, and provide backup for other supervisors or the Manager as needed.
  • Develop and deliver training in production operations, systems, and cGMP compliance.
  • Record and review Batch Production Records, In-Process Sheets, log books, time sheets, deduction cards, and other required paperwork.
  • Perform required reconciliations for controlled-substance manufactured lots.
  • Complete the final Production review of Batch Production Records before Quality review and approval; obtain corrections, monitor error rates, and initiate actions to reduce errors.
  • Initiate events and investigations, collaborate with Quality Assurance, identify potential root causes and corrective and preventive actions, and evaluate and minimize quality impact.
  • Complete events and investigations within required procedural and production-schedule timeframes.
  • Initiate and complete procedural revisions and related training modules, ensuring practices match procedures and best practices are coordinated across shifts.
  • Ensure products produced or returned to inventory are properly labeled and monitor inventories.
  • Participate in using pharmaceutical equipment for process development, scale-up, and process validation batches, and coordinate training for transferring new products and processes to commercial operations.
  • Provide input on requirements for new equipment or upgrades, and participate in equipment qualification and requalification.

Benefits

  • Competitive salaries and benefits
  • Inclusive work environment
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