Purpose

The Associate Production Technician 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.
• Request sterility certificates and ensure cleanroom readiness.
• Process cleanroom supplies and instruments, including decontamination, sterilization, and storage for production teams.
• Follow sterilization guidelines and departmental procedures; decontaminate items for re-sterilization.
• Prepare production supplies and equipment for Ethylene Oxide (ETO) and Autoclave Sterilization, including cleaning, assembly, and labeling.
• Meet or exceed production related KPI’s and goals related to but not limited to: Good Documentation Practices (GDP), adherence to attendance policy and production yield measures.
• 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 multi-task and work in a fast-paced environment.
• Self-motivated.
• Ability to secure and maintain a favorable background investigation and clearance.
• Proficiency in Microsoft Office.

Qualifications/Requirements

• High school diploma or equivalent required.
• Ability to work seated or standing for 8-10 hours.
• 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.
• Clearance of favorable background investigation required.