Quality Compliance Auditor

SUMMARY OF THE POSITION

The Quality Compliance Auditor responsibilities includes, but is not limited to provide direct quality functional support to assure quality systems compliance and customer requirements. Responsible to lead the Internal Audit Program, Regulatory Inspections and Customer Audits. Work-out strategies and action plans to maintain Quality Systems in compliance with regulatory agencies. Responsible for Inspection Readiness program. Participate in many quality site activities and processes, as required. Receives general guidance from direct supervisor, but mostly handles or works under minimum supervision.

PRIMARY RESPONSIBILITIES

1. Develop Internal Audit Schedule and ensure that internal audits are being performed per the approved schedule. Manage internal audit program and maintain internal audit log.

2. May lead or support other auditors in the execution of internal audits.

3. Help facilitate closure of CAPAs and internal audits in a timely manner. Maintain complete and accurate CAPA and Internal Audit files and records.

4. Lead efforts to continuously improve CAPA and internal audit processes. Develop, coordinate and ensure CAPA and internal audit trainings for relevant personnel.

5. Thoroughly understand the processes and investigation techniques to effectively review the investigation, root-cause, proposed actions and effectiveness plans and to ensure that the true root-cause is addressed.

6. Develop and communicate CAPA and Internal Audit metrics to management on a regular basis.

7. Support external audits, as necessary, and serve as a subject matter expert (SME) for regulatory audits, as necessary.

8. Maintain Inspection Readiness program and actively supports site regulatory inspections and executes corrective actions, as assigned.

9. Manages to obtain a comprehensive response to all previous regulatory and internal cGMP’s observations by coordinating with suppliers and service areas the evaluation of responses according to cGMP’s and Company’s or Customer requirements as applicable.

10. Coordinate the Quality Council in a monthly basis and maintain tracking of actions and minutes.

11. Acts as a coordinator for various Quality Operations projects. Tracks and summarizes steps to project completion assuring fulfillment within regulatory requirements, cGMP’s and site procedures.

12. Will perform other assignments related Quality Operations responsibilities at the direction of the Quality Systems and Regulatory Affairs Lead. Able to work little or no supervision requiring he/she have a thorough knowledge of plant operations and ability to communicate at all levels of management when required.

13. Willing to work irregular and/or rotating shifts.

14. Comply with all environmental trainings, procedures, guidelines, practices, Good Manufacturing Practices (GMPs), permit conditions and internal notifications of any environmental event.

15. Perform any other job related duties as required or that may arise in the future.

EDUCATION / EXPERIENCES / CERTIFICATIONS

• Bachelor’s Degree or higher in Science or Engineering
• Minimum of 5 years of experience in the Pharmaceutical Industry and/or manufacturing environment or related field, preferable in the areas of production, quality or compliance.
• Certified Quality Auditor and/or Certified Quality Engineer preferred.

TECHNICAL COMPETENCIES

• Communicates clearly and concisely in English / Spanish orally and written.
• Skilled at communicating insights and understanding of issues or problems.
• Breaks down communications barriers between teams, departments, and functions.
• Helps people understand how their work contributes to broader business objectives.
• Teammates trust their ideas and opinions because of in-depth knowledge and experience.
• Require reliable knowledge in the understanding of the Code of Federal Regulations, Eudralex, and any other regulation that applies to the site and current manufacturing and approved markets. Basic knowledge of computer software: Excel, Word and Power Point.
• Strong understanding of cGMP’s and regulatory Agencies applicable to the site mandated criteria.