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Quality Compliance Auditor in Richmond at Apple & Associates

Date Posted: 1/3/2019

Job Snapshot

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Job Description

Quality Compliance Auditor

This Fortune 200 Company is searching for a Quality Compliance Auditor to join their Regulatory Affairs team. In this role, will be responsible for conducting quality audits of internal, supplier, and/or clinical related operations to evaluate the level of conformance to company standards and/or regulations. In addition to direct auditing related activities, you will be required to support FDA inspection activities and develop compliance assessments and trend analysis of emerging risk areas and formulating escalation communications to management.

Quality Compliance Auditor - Accountabilities include:
  • Planning, conducting and reporting the results of internal, supplier, and/or clinical related quality audits to departmental and operational management.
  • Planning and coordinating audit and project activities using multi-discipline / multi-functional teams.
  • Identifying and escalating internal and external situations which may pose quality/compliance risks that may adversely affect business operations.
  • Assisting in the development, implementation and continuous monitoring of objectives, procedures, tracking and trending mechanisms to ensure that management is consistently informed on the status and effectiveness of compliance activities.
  • Participating in the development of company-wide audit resources through training and/or mentoring to increase the overall organizational capability.
  • Conducting analyses, consulting and assessments of various operations and processes by applying their knowledge and judgment in areas where they may have little to no previous work experience.
  • Evaluating situations to determine the potential impact.
  • Leading or participating in corrective actions and programs designed to enhance the quality and compliance of the organization.
  • Providing guidance and recommendations to management on Good Manufacturing Practices (GMP) implementation and issues resolution.
  • Maintaining confidentiality of information obtained during audits.

Quality Compliance Auditor - Qualifications include:
  • A Bachelor's degree in a physical science, engineering, or related field.
  • A minimum of 8 years of relevant experience in quality systems auditing and operations.
  • Direct FDA experience or quality/compliance experience in an FDA regulated industry (pharmaceuticals, medical devices and dietary supplements).
  • Detail orientation; strong analytical and organizational skills.
  • Strong written, verbal and presentation skills along with demonstrated ability to collaborate with others.
  • Ability to tactfully, independently and persuasively provide critical and sensitive feedback to the most senior levels of management.
  • Proficiency in conflict negotiation and resolution is preferred.
  • The ability to perform assignments in an independent and autonomous manner with minimal direct supervision.
  • Ability to utilize various computer software to include: Word, Excel, PowerPoint and Outlook.
  • Audit and/or quality certification in ISO, ASQ CQE or CQM is desirable or ability to obtain an ASQC Quality Auditor certification within one year of obtaining this position.
  • Comfortable working during non-core hours as required to assess multiple shifts and operations spanning lengthy periods.
  • The ability to travel up to 50% throughout the year (domestic and international).