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Quality Assurance Compliance Specialist

2 months ago

Miami, Florida, United States VIVEX BIOLOGICS INC Full time
Job Overview

Position Summary

The Quality Compliance Coordinator plays a vital role in overseeing and managing various quality assurance processes, including Corrective Actions & Preventive Actions (CAPA), Non-conformances (NC), Supplier Corrective and Preventive Actions (SCAR), and complaints. This position is also responsible for managing change controls related to manufacturing processes, equipment, and facilities, ensuring adherence to corporate policies and regulatory standards.

Key Responsibilities

  • Administer and oversee CAPA, NC, SCAR, complaints, planned deviations, and error corrections.
  • Provide expert guidance to ensure compliance with established procedures for non-conformance, CAPA, and related processes.
  • Support thorough investigations and root cause analyses for quality-related issues, implementing effective corrective measures.
  • Facilitate change control activities by offering expert review and feedback to ensure compliance with relevant regulations.
  • Review and manage change controls and associated documentation.
  • Identify potential risks in manufacturing processes and implement effective mitigation strategies.
  • Conduct audits and reviews of complex documents, including batch records and validation processes.
  • Assist in the preparation of Quality Management Review and Process Change Control Metrics.
  • Author, review, and approve Quality Management System (QMS) Standard Operating Procedures (SOPs) and policies.
  • Observe manufacturing practices to promote best practices and continuous improvement.
  • Prepare regular updates and project status reports on Quality Assurance activities.
  • Communicate quality metrics and improvement initiatives to leadership.
  • Provide insights and oversight for trend reporting to identify and address process shifts.
  • Ensure all documentation is maintained in compliance with internal procedures and regulatory requirements.
  • Facilitate quality training sessions with cross-functional teams as needed.
  • Foster a collaborative environment within the Quality Assurance department and related teams.
  • Report project progress to Quality Leadership and other relevant stakeholders.

Qualifications

  • Bachelor's degree in engineering or a related technical/scientific field (e.g., Biology, Chemistry).
  • A minimum of 5 years of experience in a quality or engineering role.
  • Experience with change control processes is essential.
  • Strong understanding of FDA, AATB, and cGTP guidelines is preferred.
  • Experience in the Tissue Banking, Pharmaceutical, Medical Device, or Biologics sectors.
  • Familiarity with Non-Conformance, Planned Deviation, Complaint, and CAPA processes.
  • Proficient in relevant software applications (Microsoft Project, Word, Excel, PowerPoint).
  • Excellent oral and written communication skills.
  • Strong organizational and analytical abilities.
  • Project management skills are advantageous.
  • Ability to influence and lead significant changes effectively.
  • American Society for Quality (ASQ) certification is preferred.
  • Certified Tissue Bank Specialist (CTBS) certification is preferred.

Working Conditions

Willingness to travel as necessary. The role involves working in an office and laboratory environment, with occasional access to clean rooms and exposure to human tissue and associated hazards.

Physical Requirements

The position requires prolonged periods of sitting, with occasional lifting or moving of up to 20 pounds.

This job description does not restrict management's right to assign or reassign duties and responsibilities at any time.

Vivex Biologics, Inc. is an equal opportunity employer and prohibits any form of workplace discrimination or harassment.

Vivex Biologics, Inc. complies with the Americans with Disabilities Act (ADA).