Production Technician

Extremity Care; San Antonio (TX); On-site; USD 36,000 - 60,000; Full time

Job summary

Extremity Care is seeking a Production Technician I to support human tissue manufacturing under GMP and FDA guidelines. You will perform aseptic processing, maintain sterile conditions, and ensure documentation accuracy across controlled records.

This on-site role requires 8–10 hour shifts, overtime as needed, and strict adherence to SOPs. Candidates should have at least 1 year of aseptic experience and a high school diploma or equivalent.

Qualifications

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

Responsibilities

• Complete assigned training on SOPs by required deadlines.
• Maintain competency in aseptic technique and sterile field protocols via 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 yield.
• Identify and report deviations and nonconformances to management and QA.

Skills

Independent work

Attention to detail

Communication

Ethics and integrity

Leadership

Multitasking

Aseptic technique

Documentation accuracy

Microsoft Office

SOP compliance

Education

High school diploma or equivalent

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