Production Technician 1 - Tissue Processing

Required Shift: Tuesday-Friday 6AM - 4:30pm
Hiring for Multiple Locations

Purpose

The Production Technician I is responsible for developing and maintaining proficiency in human tissue manufacturing procedures and support processes to execute and support the production schedule.

Responsibilities

• Develop and maintain competency in knowledge of aseptic technique and sterile fields
• Complete self-administered read and understand training for standard operating procedures to ensure completion by assigned due dates
• Manufacture finished product from human tissue using aseptic technique in accordance with standard operating procedures
• Use good judgement to maximize manufacturing product yield based on established production plans
• Decontaminate, wrap, and autoclave reusable manufacturing supplies in accordance with standard operating procedures
• Accurately and concurrently document completion of manufacturing processes and support tasks on controlled records in accordance with good documentation practices (GDP), standard operating procedures, and regulatory requirements
• Identify and report occurrences of deviations/nonconformances to management and quality assurance
• Support execution of cleanroom/equipment cleaning, decontamination, maintenance, calibration, and environmental monitoring
• Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating procedures
• Maintain acceptable attendance and punctuality for scheduled work hours and meetings. Ensure completion of assigned tasks and responsibilities within defined timeframes
• Flexibility to work outside of normal business hours during weekdays or weekends with reasonable advance notice to support business/operational needs when necessary
• Perform other duties as assigned

Skills

• Ability to work independently and in a team environment
• Excellent attention to detail and organization
• Excellent written and verbal communication
• Highest level of ethics and integrity
• Ability to lead and motivate the right behaviors
• Ability to multi-task and work in a fast-paced environment
• Strong technical writing
• Effective project management
• Ability to work seated or standing for 8-10 hours
• Proficiency in Microsoft Office

Qualifications/Requirements

• High school diploma or equivalent required
• At least 1-3 years of hands-on experience with aseptic technique required
• At least 1 year of experience 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)
• Ability to push, pull or otherwise transport objects or materials weighing up to 25 lbs
• Ability to document work with accurately and with legible handwriting
• Successful completion of a favorable background investigation required