Associate Production Technician

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.