Supervisor, Manufacturing Operations - 3rd Shift (Manufacturing)

Description:

The Supervisor of Manufacturing Operations will manage and oversee the daily production activities to ensure adherence to cGMPs and SOPs, optimize production efficiency, and improve quality while minimizing raw material waste. This role involves supervising production schedules, leading a team of operators and technicians, ensuring smooth operations, and upholding high safety and quality standards.

Essential Functions:

• Supervise, train, and inspire production staff to drive high performance and productivity. Offer daily guidance and support to team members, ensuring alignment with operational objectives. Manage the training and development of personnel to ensure adherence to good manufacturing practices (cGMPs) while improving the quality and quantity of work. Handle employee relations, conduct interviews for new hires, and manage performance reviews. Monitor daily production and operations to ensure departmental quality standards are met. Oversee and ensure that operating supply and equipment costs align with or surpass expectations.
• Conducts regular inspections of department facilities and equipment to ensure compliance with SOPs, cGMPs, and safety regulations. Schedules and generates work orders for maintenance and repairs to minimize equipment breakdowns and enhance efficiency and productivity. Collaborates with the Engineering team on equipment changes and upgrades. Contributes to the development and updates of standard operating procedures for current and future processes.
• Ensures raw material usage and product yields meet or exceed standards.
• Works closely with the department manager to assess production needs, coordinating, scheduling, and prioritizing tasks to enhance customer service, as well as departmental production and efficiency.
• Provides technical support to staff on equipment and processes, troubleshooting issues and developing control techniques. Prepares and maintains production tooling, closely monitoring performance and making adjustments as needed, while evaluating the effectiveness of the tooling.
• Monitors the department to ensure safety protocols are being followed and addresses any unsafe conditions promptly.

 

Education:

• High School or GED - Required
• Bachelors Degree (BA/BS) Manufacturing engineering, industrial engineering, or a related field - Preferred

Experience:

• 5 years or more in manufacturing experience including supervisory experience in Softgel; Pharmaceutical & Manufacturing

Skills:

• Ability to read, write, and communicate in English at a level to facilitate the understanding terminology of the job. - Advanced
• Ability to comprehend and follow written and verbal procedures or instructions - Advanced
• Have basic math and mechanical skills - Advanced
• Ability to operate forklift and pallet movers. (Preferred) -

Specialized Knowledge:

• Provide technical expertise for Solid Dosage formulation such as Tablet and Capsule. Knowledge of standardization of production norms based on FDA & DEA regulations.
• Specialized in Osmotic Controlled Release Oral Delivery System (OROS) technology. Knowledge of Pharmaceutical Laser Drilling and Ink Printing Machine for specialized solid oral dosage form.
• Requires knowledge of 6 sigma and Lean Principles to reduce cycle time and cost while maintaining or increasing Production Quality standard
• Coordinate and interfaces with Engineering for equipment Preventive Maintenance and Validation such as IQ, OQ and PQ.
• Responsible for Production Planned deviation, CAPA, Change control. Write and update Standard Operating Procedure (SOP). Investigate customer complain
• Manages department audits to ensure all department operations are in compliance with cGMP and related SOPs. Audit Employee training data and Production Batch Record
• Required technical knowledge on Liquid Filled Hard Gelatin Capsule manufacturing and Machinery
• Provide technical support for Extended Release coated Pellets and Tablets; Capsule filled with Pellets and Tablet.