Production Technician

Extremity-Care; San Antonio (TX); On-site; USD 42,000 - 62,000; Full time

Job summary

Extremity-Care is seeking a Production Technician I to develop proficiency in human tissue manufacturing and GMP-compliant processes. The role emphasizes aseptic technique, precise documentation, and strict adherence to SOPs and regulatory standards in a fast-paced environment.

The candidate will maintain equipment cleanliness, contribute to production efficiency, and report deviations while ensuring on-time on-site scheduling and compliance with GDP and FDA requirements.

Qualifications

• High school diploma or equivalent is required.
• At least 1 year of hands-on experience with aseptic technique.
• Experience in an FDA-regulated environment preferred.
• An associate's or bachelor's degree may substitute for one year of experience.
• Background investigation clearance required.

Responsibilities

• Complete training on SOPs by required deadlines.
• Maintain competency in aseptic technique and sterile field protocols.
• Manufacture finished products from human tissue using aseptic technique.
• Optimize tissue processing efficiency and maximize yield.
• Identify and report deviations to management and QA.
• Perform cleanroom and equipment cleaning, calibration, and monitoring.
• Decontaminate, wrap, and autoclave reusable supplies per SOPs.
• Document manufacturing processes accurately in controlled records.
• Ensure documentation complies with GDP, SOPs, and regulations.
• Attend on-site shifts and mandatory overtime as required.
• Maintain knowledge of FDA regulations and internal SOPs.
• Perform other duties as assigned.

Skills

Independent work & teamwork

Attention to detail

Written & verbal communication

Ethics & integrity

Leadership & motivation

Multitasking & fast-paced work

Aseptic technique

Documentation accuracy

Microsoft Office

Follow SOPs & regulatory guidelines

Education

High school diploma or equivalent

Associate or Bachelor's degree substitution

Job description

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