Supervisor Pharmaceutical Coating – 4th Shift

Key responsibilities for this role include:

• Ensure that assignments are completed on schedule following established policies and procedures. Guide and direct staff in production areas to assure compliance with the Production schedule.
• Monitor production output and quality of work on the line versus established standards and initiate corrective actions as necessary working in conjunction with Production management, Quality Assurance, Maintenance, Engineering, etc.
• Monitor and ensure proper equipment operation and all safety rules and guidelines are followed. Monitor work areas, ensuring appropriate cleanliness, orderly condition and cGMP compliance. Prepare and approve rooms and equipment for inspection. Perform room releases as necessary. Ensure that all equipment and room logs are current and accurate.
• Coordinate and oversee the work of operators in other areas as necessary and act as a back-up to other supervisors or Manager as necessary.
• Develop and perform training of personnel in Production operations, systems and cGMP compliance as necessary.
• Record/Review data on Batch Production Records, In-Process Sheets, Log Books, and Time Sheets, deduction cards and other paperwork as required. Perform the required reconciliations associated with Controlled Substance manufactured lots. Perform final Production review of Batch Production Records prior to Quality review/approval. Obtain corrections as necessary and monitor error rates and initiate corrective actions to reduce errors.
• Initiate events or investigations including collaboration with QA, identifying potential root causes and corrective and preventative actions to assure impact on quality is evaluated and minimized. Complete events and investigations within required timeframes including both procedural and production schedule based deadlines.
• Initiate and complete procedural revisions and corresponding training modules assuring practice matches procedure and best practices are coordinated with all shifts.
• Ensure all products produced or returned to inventory are properly labeled and monitor inventories.
• Participate in the use of Pharmaceutical equipment for Process Development, Scale-up, and Process Validation batches and coordinate the training necessary to transfer new products/processes to commercial operations.
• Provide input into requirements for new equipment or equipment upgrades and participate in the qualification/requalification of equipment.

The minimum qualifications for this role are:

• Minimum of a Bachelor of Science Degree (or equivalent) and 2 – 4 years of relevant experience required. However, a combination of experience and/or education will be taken into consideration.