Responsible for supervising the daily operations (products and people), in a unit. Ensuring the adherence to all regulatory and safety requirements and fulfilling production output, quality and time requirements. Develop and maintains a team environment with high levels of participation from all production associates. Responsible for the aseptic filling of all products assuring processes are performed in compliance with cGMP's and following Standard Operating Procedures (SOPs).

Responsibilities

1. Responsible for scheduling and supervising designated operations
2. Participate in planning production actives
3. Ensures that personnel is effectively utilized to meet production needs
4. Ensure compliance with GMP, ISO 90001, regulatory requirements, dept/bldg. Safety rules and applicable company policies and procedures
5. Utilize human resources effectively, train and coach and provide developmental opportunities for personnel to increase cross training and scheduling flexibility
6. Evaluate the performance of personnel; recommend salary and or promotional actions. Take appropriate actions to resolve marginal performs.
7. Maintain a positive working environment that encourages personnel participation, team work and mutual support
8. Coordinates actives with materials managements, QA and engineering to insure production, productivity and quality standards are met.
9. Responsible to implement safety policies and ensure that personnel are trained in and follow safe work procedures
10. Ensure proper maintenance and work place organization of equipment and work area
11. Maintain and supply raw material budgets within approved levels.
12. Set goals and measures with the Manufacturing Manager. Work with minimal supervision to perform duties and assignments. Seeks input and guidance on complex problems or new activities
13. Solve and trouble shoot routine daily operations problems.
14. Empowered with authority to act, by making decisions that ensure the safety of all personnel.
15. Make decisions that ensure the quality and integrity of the product.

Required Knowledge, Skills and Abilities

• Understanding of lot control relative to medical industry
• Understanding of Good Manufacturing Practices and ISO Standards
• Ability to lift 50 pounds
• Good communication and interaction skills
• Ability to work overtime as necessary
• Computer literate
• Ability to handle multiple tasks
• Ability to interact with numerous departments
• Ability to work without independently and delegate tasks as necessary

Required Education and Experience

• Minimum High School graduate or equivalent
• Preferred Bachelor’s degree in Science or Engineering
• Preferred 3-5years’ industry experience directly associated with aseptic manufacturing
• Preferred 2 + years related supervisory experiences
• Equivalent combination of education and/or experience may be considered