Job Responsibilities
• Participate in internal and external audits.
• Manage company records in accordance with regulatory requirements and company policies.
• Author, review, revise, and implement standard operating procedures (SOP’s) for the QMS.
• Analyze and implement improvements in equipment management processes to increase scalability and consistency of performance. Develop associated programs and create job aides.
• Capture, trend, analyze quality data, and identify areas for improvement.
• Be involved in the resolution of Nonconformances (NONC) and Corrective Action Preventive Action (CAPA) events.
• Collaborate with the cross-functional teams to achieve defined business objectives.
• Use creative problem-solving skills to identify, solve, or improve processes.
• Review records for accuracy.
• Utilize the Master Site Validation Plan to minimize logistical challenges in completing equipment tasks.
• Coordinate with approved vendors to perform equipment calibrations, preventative maintenance, and repairs.
• Perform equipment repairs, calibrations, and/or maintenance as required.
• Prepare, coordinate, and lead training of Equipment Engineering Technicians and/or members of other departments.
• Other duties as assigned