3rd Shift Manufacturing Compliance Coordinator

The 3rd Shift Manufacturing Compliance Coordinator is responsible for ensuring quality oversight of sterile and aseptic manufacturing processes. The individual will work closely with various departments including Quality, Regulatory, Materials, and Manufacturing teams to ensure compliance with regulations and procedures throughout the manufacturing process.
The ideal candidate will have, or be able to develop, a strong level of understanding in all aspects of sterile drug manufacturing. The individual will also demonstrate a process improvement mindset, leadership skills, and the ability to collaborate in a cross-functional environment to drive sustainable resolutions in accordance to guidance and industry standards. The essential functions are representative, but are not inclusive of all responsibilities.

• Drives a culture of quality at the source, compliance, and right the first time practices through coaching and mentoring personnel in real time.
• Performs routine diligent and accurate reviews of Manufacturing Batch Records, room checklists, logbooks, and other paperwork in accordance with approved SOPs.
• Performs scheduled Gemba walks of Production areas and elevates opportunities for improvement to appropriate personnel.
• Performs and supports document change controls of work instructions including standard operating procedures, job aids, etc., document change request of Manufacturing Batch Records, investigations, change controls, audits, and reviews as related to the manufacturing floor and operations department.

• Jointly responsible for corrective and preventative action development with area leaders and driving change to ensure key performance indicators are within target.
• Facilitates training opportunities between subject matter experts and trainees in all aspects of the manufacturing process and performs trainings when possible as related to knowledge and ability.
• Collaborates with and provides real time coaching to all levels of the organization in order to ensure compliant and complete documentation in support of Good Manufacturing and Documentation Practices.

• Special assignments relating to Good Manufacturing Practices and compliance as needed.