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Compliance Auditor

2 months ago

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

Purpose of the Role

The Compliance Auditor plays a critical role in the establishment and execution of a robust internal auditing framework that adheres to Standard Operating Procedures, as well as FDA, AATB, ISO 9001:2015, and state regulations. This position requires exceptional verbal and written communication abilities.

Key Responsibilities

Internal Audit Functions

  1. Assist in the formulation of internal audit strategies and timelines.
  2. Conduct regular inspection rounds across various departments.
  3. Carry out periodic internal audits of all quality systems to ensure adherence to federal, state, and accreditation standards.
  4. Prepare inspection findings and audit reports to relay results to relevant management personnel.
  5. Perform additional tasks and responsibilities as assigned.

Quality Assurance Duties

  1. Stay informed about and uphold Vivex Biologics, Inc. policies and procedures;
  2. Maintain awareness of applicable regulatory, statutory, and accreditation standards, as well as current Good Tissue Practices;
  3. Facilitate site inspections conducted by regulatory agencies;
  4. Accountable for reporting any discrepancies, errors, and deviations in Vivex documentation as per established procedures.
  5. Engage in the investigation and implementation of corrective actions, along with documentation of complaint files and nonconformance reports as necessary;

Qualifications

Education:

· A Bachelor's Degree is preferred.

Experience:

· A minimum of 2 years of auditing experience in a GMP-related environment is required.

· Strong understanding of quality systems and regulatory standards (21 CFR Part 11/210/211) is preferred.

· Familiarity with technical concepts necessary for cGTP or cGMP auditing in the tissue, medical device, biologics, or pharmaceutical sectors is preferred.

· Experience with electronic document management systems is preferred.

Skills:

· Exceptional interpersonal, verbal, and written communication skills are essential in this collaborative environment.

· Ability to manage multiple assignments in cooperation with other departments to ensure successful project completion.

· Strong organizational skills and meticulous attention to detail are crucial; excellent writing and editing capabilities are required.

· Proficiency in computer applications and word processing, particularly with MS Word.

· Familiarity with Adobe Acrobat, Visio, Adobe Sign, and DocuSign is preferred.

· Advanced knowledge of Microsoft Suite (e.g., Excel, Word, Visio, etc.) is essential.

Certifications:

CTBS or ASQ certification is preferred.

Work Environment

This role is primarily office-based in a quiet environment. Occasional evening and weekend work may be necessary. The facility maintains a cool temperature.

Physical Requirements

While performing the duties of this position, the employee is frequently required to sit for extended periods. Occasionally, the employee may need to lift or move items weighing up to 20 pounds.

Direct Reports

This position does not have any direct reports.

Nothing in this job description limits management's right to assign or reassign duties and responsibilities at any time.

VIVEX is an equal opportunity employer (EEO) and strictly 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. This policy applies to all aspects of employment, including recruiting, hiring, placement, promotion, termination, layoff, transfers, leaves of absence, compensation, and training.

VIVEX adheres to the Americans with Disabilities Act (ADA), which prohibits discrimination against qualified individuals with disabilities who can perform the essential functions of a job with or without reasonable accommodation.