Quality Assurance Engineer I

6 days ago


Miami, Florida, United States VIVEX BIOLOGICS INC Full time
Job Title: Quality Assurance Engineer I

Job Summary:

Vivex Biologics Inc. is seeking a highly skilled Quality Assurance Engineer I to join our team. The successful candidate will be responsible for developing, implementing, and maintaining quality metrics to support operations at Vivex Biologics Inc.

Key Responsibilities:

  • Develop and implement quality metrics to support operations
  • Collaborate with cross-functional teams to ensure compliance with regulatory requirements
  • Conduct data analysis and make recommendations to ensure tissue safety/quality and compliance with standards
  • Support investigations and root cause analyses for quality-related issues
  • Implement effective corrective actions and ensure personal and company compliance with all federal, state, company and regulatory bodies' regulations, policies, and procedures

Requirements:

  • Bachelor's degree in engineering or a related technical discipline (e.g. Biology, Chemistry, etc.)
  • At least 1 year of experience in related Engineering or Quality role
  • Strong knowledge of FDA, AATB, and cGTP guidelines preferred
  • Experience in Tissue Banking, Pharmaceutical, Medical Device, or Biologics industry
  • Experience with Non-Conformance, Deviation, Complaint, and Corrective and Preventive Actions (CAPAs)
  • Strong knowledge of relevant software applications (Microsoft Project, Word, Excel, and PowerPoint)
  • Effective oral, written, communication, and presentation skills
  • Strong analytical and problem-solving skills
  • Project management skills preferred

Working Conditions:

Office environment, laboratory environment, occasional clean room access, subjected to human tissue and associated hazards and biohazards

Physical Requirements:

While performing the duties of this job, the employee is regularly required to sit for prolonged periods of time. The employee may occasionally be required to pull, lift and/or move up to 20 pounds.

Vivex Biologics Inc. is an equal opportunity employer (EEO) and expressly prohibits any form of workplace discrimination and/or harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status.



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