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Quality Assurance Specialist

2 months ago

Pompano Beach, Florida, United States BioStem Technologies Full time
Job Summary

We are seeking a highly motivated and detail-oriented Quality Assurance Associate to join our team at BioStem Technologies. As a key member of our quality team, you will be responsible for ensuring the quality and compliance of our products, from incoming materials to final disposition.

Key Responsibilities
  • Verify compliance with Standard Operating Procedures (SOPs) and Good Documentation Practices.
  • Conduct label verification throughout manufacturing processes.
  • Ensure accurate and complete documentation related to batch release, quality control, and lot status.
  • Manage document control, including creation and revision of SOPs.
  • Develop and maintain logbooks and training matrices.
  • Perform QA release of components and raw materials, and assist with final shipping review.
  • Investigate CAPAs, deviations, OOS, and non-conformances.
  • Participate in continuous improvement initiatives to enhance efficiency, accuracy, and compliance.
Requirements
  • High School Diploma or AA degree.
  • Knowledge of GMP and safety regulations.
  • Experience with AATB accreditation and/or FDA 21CFR1271 regulations preferred.
  • Excellent communication and problem-solving skills.
  • Proficiency in Microsoft Office and MasterControl.
Working Conditions

The work environment is primarily a laboratory production environment with some warehouse duties. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.