Production Technician I

Production Technician I

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
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
Clearance of favorable background investigation required
The compensation range listed reflects the full salary range for the position and is not indicative of the starting salary. Final compensation will be determined based on job-related factors, including experience, qualifications, and internal equity.