Production Technician I

Responsibilities

• Complete assigned training on standard operating procedures (SOPs) by required deadlines
• Maintain competency in aseptic technique and sterile field protocols through ongoing training
• Manufacture finished products from human tissue using aseptic technique in compliance with SOPs
• Apply good judgment to optimize tissue processing efficiency and maximize product yield
• Identify and report deviations and nonconformances to management and Quality Assurance
• Perform cleanroom and equipment cleaning, decontamination, calibration, and environmental monitoring
• Accurately and concurrently document manufacturing processes and support tasks in controlled records
• Ensure all documentation complies with GDP, SOPs, and regulatory requirements
• Report to work on-site and on time for scheduled shifts, including mandatory overtime when required
• Attend all scheduled meetings, training sessions, and appointments as assigned
• Perform other duties as assigned

Qualifications/Requirements

• A high school diploma or equivalent required
• At least 1 year of hands-on experience with aseptic technique required
• Experience working in an FDA-regulated environment preferred
• A higher level of education (such as an associate’s or bachelor's degree in a related field) may be considered in lieu of 1-3 years of required experience
• Clearance of favorable background investigation required