Tissue Inventory Technician I

Purpose

The Tissue Inventory Technician I will play a crucial part in receiving and managing the acquired tissues and supporting the overall success of the Tissue Acquisition Program. This role requires meticulous attention to detail, strong organizational skills, and the ability to work collaboratively within a fast-paced and regulated environment. Shift expectations may be revised at management’s discretion with adequate notice.

Responsibilities

· Receive, inspect, document, and store all incoming donor tissue in accordance with established protocols and regulatory standards

· Remove tissues from storage for placement with production team or to satisfy tissue discard requests from Quality Assurance

· Maintain accurate and up-to-date records of tissue inventory ensuring traceability and compliance with regulatory requirements

· Perform routine inspections of stored tissues to ensure quality and compliance with established standards

· Collaborate with the Quality Assurance team to address any discrepancies and implement corrective actions

· Perform routine cleaning of tissue storage equipment in accordance with established protocols

· Accurately enter and update information in the inventory management system

· Prepare and maintain detailed documentation for all tissue inventory transactions

· Work closely with the Tissue Receiving Manager to coordinate inventory levels

· Collaborate with other departments to include Quality Assurance, Logistics, and Operations to support overall program objectives

· Assist in covering business needs during off hours such as receiving goods on weekends or responding to environmental condition alarms

· Assist with receiving production supplies as needed

· Ensure daily cleanliness of tissue receiving and storage areas

· Perform administrative tasks as needed

· 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 operate a company vehicle with an acceptable driving record

· Knowledge of tissue banking industry and regulatory requirements is a plus

· Ability to multi-task and work in a fast-paced environment

· Ability to lift to 20 pounds and stand for extended periods of time

· Strong technical writing

· Effective project management

· Proficiency in Microsoft Office

Qualifications/Requirements

· High school diploma or equivalent required from an accredited institution.

· Previous experience working in an FDA regulated environment highly preferred

· Clearance of favorable background investigation required