Supervisor, Pharmaceutical Packaging – 2nd Shift

Role Summary

Supervisor, Pharmaceutical Packaging – 2nd Shift oversees production staff in packaging operations, ensures assignments are completed on schedule in accordance with policies and procedures, and maintains compliance with cGMP. The role involves monitoring production output and quality, ensuring equipment operation and safety, and providing training and leadership to production personnel. Back-up coverage for other supervisors or the manager may be required.

Responsibilities

• 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.

Qualifications

• Required: A Bachelor's degree (or equivalent) and 2 - 4 years of relevant production experience is preferred. However, a combination of experience and/or education will be taken into consideration.
• Required: Must possess good communication, time management, organizational, interpersonal, leadership, writing and basic computer skills including Microsoft Word and Excel, Plateau, Trackwise and MTime. Knowledge of industry practices and standards. Solves routine problems of limited scope and complexity following established policies and procedures.
• Required: Ability to lift up to 50 pounds.
• Required: Ability to stoop, climb ladders, or stairs, stand or sit for extended periods of time.
• Required: Ability to wear a respirator.
• Required: Ability to hear an alarm.
• Required: Ability to identify small defects.
• Required: Ability to distinguish between colors.

Education

• Bachelor's degree (or equivalent) and 2-4 years of relevant production experience, or combination of experience and education.

Additional Requirements

• Ability to lift up to 50 pounds.
• Stand or sit for extended periods; ability to stoop, climb ladders or stairs.
• Ability to wear a respirator; ability to hear alarms; ability to identify small defects; ability to distinguish colors.