Production Technician (Human Tissue Processing)

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

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

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.

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

Proficient in aseptic technique

Excellent documentation accuracy

Proficiency in Microsoft Office

Ability to follow SOPs and regulatory guidelines with precision

Physical Requirements

Ability to work seated or standing for 8 – 10 hours

Ability to lift, push, pull or otherwise transport objects or weighing up to 25lbs

Qualifications/Requirements

High school diploma or equivalent required

At least 1 year of hands-on experience with aseptic technique required

Experience working in an FDA-regulated environment preferred

An associate's or bachelor's degree in a related field may be substituted for the required one (1) year of experience

Clearance of favorable background investigation required