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Production Technician

2 months ago

TX United States Extremity Care Full time
Job Summary

Extremity Care is seeking a highly skilled Production Technician to join our team. As a key member of our production team, you will be responsible for developing and maintaining proficiency in human tissue manufacturing procedures and support processes.

Key Responsibilities
  • Develop and maintain a working knowledge of FDA 21 CFR 1271, AATB standards, current Good Tissue Practices (cGTP), Good Documentation Practices (GDP), and other relevant industry standards.
  • Develop and maintain competency in knowledge of aseptic technique and sterile fields.
  • Complete self-administered training for standard operating procedures to ensure completion by assigned due dates.
  • Manufacture finished product from human tissue using aseptic technique in accordance with standard operating procedures.
  • Use good judgment to maximize manufacturing product yield based on established production plans.
  • Support execution of cleanroom/equipment cleaning, decontamination, maintenance, calibration, and environmental monitoring.
  • Decontaminate, wrap, and autoclave reusable manufacturing supplies in accordance with standard operating procedures.
  • Accurately and concurrently document completion of manufacturing processes and support tasks on controlled records in accordance with good documentation practices (GDP), standard operating procedures, and regulatory requirements.
  • Identify and report occurrences of deviations/nonconformances to management and quality assurance.
Requirements
  • High school diploma or equivalent.
  • Associate degree in a life science or certification in surgical technology (CST) (or related certification) preferred.
  • At least 6 months of hands-on experience with aseptic technique required.
  • At least 1 year of experience in an FDA regulated environment preferred.
Skills and Abilities
  • Attention to detail and organizational skills.
  • Self-motivated.
  • Effective verbal and written communication skills.
  • Ability to work in a team environment and independently.
  • Experience working with Microsoft Office (Excel, PowerPoint, Word etc.)
  • Ability to secure and maintain a favorable background investigation and clearance.