Production Technician I (Human Tissue Processing) - Bravo Shift

Extremity Care, LLC; San Antonio (TX); On-site; USD 33,000 - 37,000; Full time

Job summary

Extremity Care, LLC in Texas is seeking a Production Technician I to develop proficiency in human tissue manufacturing and GMP compliance, executing production schedules on-site. This role requires strict adherence to FDA regulations and GMP standards.

The responsibilities include completing SOP trainings, maintaining aseptic technique competency, manufacturing products using aseptic methods, documenting processes, and reporting deviations.

Qualifications

• High school diploma or equivalent 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 the required experience.
• Background check clearance required.

Responsibilities

• Complete SOP training by required deadlines.
• Maintain competency in aseptic technique and sterile field protocols.
• Manufacture finished products from human tissue using aseptic technique according to SOPs.
• Identify and report deviations and nonconformances.
• Perform cleanroom and equipment cleaning, decontamination, calibration, and environmental monitoring.
• Document manufacturing processes accurately in controlled records.
• Ensure documentation complies with GDP, SOPs, and regulatory requirements.
• Attend scheduled meetings, training, and appointments.

Skills

Aseptic technique

Attention to detail

Regulatory knowledge

Documentation

Teamwork

SOP compliance

Microsoft Office

Communication

Ethics integrity

Multi-tasking

Education

High school diploma

Job description

BRAVO SHIFT: TUESDAY - FRIDAY 3:30PM - 2:00AM

Pay: $21.49/Hourly with 15% Shift Differential

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