Production Associate

6 days ago


San Antonio, Texas, United States Extremity Care Full time

Job Title: Production Associate - Human Tissue Manufacturing

About Us

At Extremity Care, we are committed to providing high-quality human tissue products that meet the needs of our customers. We are seeking a skilled Production Associate - Human Tissue Manufacturing to join our team and contribute to our mission.

Job Summary

The Production Associate - Human Tissue Manufacturing will be responsible for supporting the production of human tissue products, including preparing production supplies and equipment, conducting quality control checks, and ensuring compliance with regulatory requirements.

Responsibilities

The key responsibilities of this role include:

  • Preparation of production supplies and equipment, including cleaning, assembly, and labeling.
  • Conducting quality control checks to ensure compliance with regulatory requirements.
  • Requesting sterility certificates and ensuring cleanroom readiness.
  • Processing cleanroom supplies and instruments, including decontamination, sterilization, and storage for production teams.
  • Following sterilization guidelines and departmental procedures; decontaminating items for re-sterilization.
  • Preparing production supplies and equipment for Ethylene Oxide (ETO) and Autoclave Sterilization.
  • Meeting or exceeding production-related KPIs and goals related to but not limited to: Good Documentation Practices (GDP), adherence to attendance policy, and production yield measures.
  • Accurately documenting completion of manufacturing processes and support tasks on controlled records in accordance with good documentation practices (GDP), standard operating procedures, and regulatory requirements.
  • Identifying and reporting occurrences of deviations/nonconformances to management and quality assurance.
  • Supporting execution of cleanroom/equipment cleaning, decontamination, maintenance, calibration, and environmental monitoring.
  • Maintaining 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.
  • Maintaining acceptable attendance and punctuality for scheduled work hours and meetings, ensuring completion of assigned tasks and responsibilities within defined timeframes.
  • Flexibility to work outside of normal business hours during weekdays or weekends with reasonable advance notice to support business/operational needs when necessary.
Requirements

To be successful as a Production Associate - Human Tissue Manufacturing, you must possess the following skills and qualifications:

  • Able 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.
  • Able to multi-task and work in a fast-paced environment.
  • Self-motivated.
  • Able to secure and maintain a favorable background investigation and clearance.
  • Proficiency in Microsoft Office.
  • High school diploma or equivalent required.
  • Able to work seated or standing for 8-10 hours.
  • Able to push, pull or otherwise transport objects or materials weighing up to 25 lbs.
  • Able to document work accurately and with legible handwriting.
Compensation

We offer a competitive salary range of $17.07 per hour, plus benefits and opportunities for professional growth and development.



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