Production Technician I (Tue-Fri, 3:30 PM - 2:00 AM)

Work Schedule: Tuesday - Friday, 3:30 PM - 2:00 AM

Purpose

The Production Technician I is responsible for developing and maintaining proficiency in human tissue manufacturing procedures and related support processes to execute and sustain the production schedule. This role requires strict adherence to FDA regulations, industry standards, and Good Manufacturing Practices (GMP).

Responsibilities

• Develop and maintain working knowledge of FDA 21 CFR 1271, AATB standards, current Good Tissue Practices (cGTP), Good Documentation Practices (GDP), and other relevant industry regulations
• 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
• Decontaminate, wrap, and autoclave reusable manufacturing supplies in accordance with SOPs
• 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

Skills

• Strong attention to detail and organizational skills
• Self-motivated with the ability to prioritize tasks effectively
• Strong verbal and written communication skills for accurate documentation
• Ability to follow SOPs and regulatory guidelines with precision
• Ability to work effectively in a team and independently in a fast-paced environment
• Experience using Microsoft Office Suite (Excel, PowerPoint, Word, Outlook, etc.)
• Ability to work seated or standing for 8-10 hours
• Ability to lift, push, or pull objects weighing up to 25 lbs as needed
  
   

Qualifications/Requirements

• High school diploma or equivalent required
• At least 1-3 years 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
• Successful completion of a favorable background investigation required