Production Technician I (Human Tissue Processing) - Alpha Shift

Extremity Care, LLC; San Antonio (TX); On-site; USD 29,000 - 32,000; Full time

Job summary

Extremity Care, LLC is seeking a Production Technician I to develop proficiency in human tissue manufacturing and GMP-compliant processes. You will work on-site in a fast-paced environment, following FDA regulations and SOPs to sustain the production schedule.

Responsibilities include training on SOPs, aseptic technique, manufacturing finished products, documenting processes, and ensuring GDP and regulatory compliance. Shift: Alpha shift Tue-Fri 6:00am-4:30pm; pay $21.49 per hour.

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 or bachelor’s degree may substitute for the required year of experience.
• Clear background investigation required.

Responsibilities

• Complete required SOP training by deadlines.
• Maintain competency in aseptic technique and sterile field protocols.
• Manufacture finished products using aseptic technique per SOPs.
• Optimize tissue processing efficiency and product yield.
• Identify and report deviations to management and QA.
• Perform cleanroom and equipment cleaning, calibration, and environmental monitoring.
• Document manufacturing processes accurately in controlled records.
• Ensure documentation complies with GDP, SOPs, and regulatory requirements.
• Attend on-site shifts and mandatory overtime as required.

Skills

Independent work

Attention to detail

Communication

Ethics and integrity

Leadership

Multi-tasking

Aseptic technique

Documentation accuracy

MS Office

Education

High school diploma or equivalent

Associate or Bachelor’s degree substitution for experience

Tools

Microsoft Office

Job description

ALPHA SHIFT: TUESDAY - FRIDAY 6:00AM - 4:30PM

Pay: $21.49/Hourly

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