Sr. Mock Audit - Ex-FDA
On Assignment, Inc./Oxford Global Resources

Philadelphia, Pennsylvania

This job has expired.


Summary:

Oversee system improvements, selection and implementation of technological advances within the scope of the quality system. Establish and act upon trend analysis and other metrics to improve business unit/ area quality systems and/or regulatory compliance. Perform quality system and business process audits as assigned. Analyze existing processes and implements process improvements using quality standards. Ensure that products meet design specifications and are within quality management limits and standards via the internal audit process. Responsible for maintaining and continuously improving the quality system and achieving quality objectives through daily actions.

Project Details:

  • Perform business quality system audits, including audit preparation, conducting audits, writing audit reports, communicating findings to suppliers, business, and stakeholders, and audit follow-up.
  • Continuously improve the effectiveness of existing quality systems and processes by converting quality system related deficiencies identified through audit findings into improved system and process practices.
  • Review and approve corrective action plans and actions as a result of audit findings.
  • Effectively execute and/or follow-up on CAPA (Corrective and Preventive Action) Quality System non-conformance or improvements.
  • Make decisions with some level of oversight.
  • Verify closure of corrective actions and preventive actions from audits.
  • Determine statistical sampling of documents and records to be reviewed during audits.
  • Prepare audit trend reports.
  • Support sites, affiliates, departments, and areas across the business to sustain compliance against applicable standards and regulations.

Job Experience:
  • Perform business quality system audits - including audit preparation, conducting audits, writing audit reports, communicating findings to suppliers, business, and stakeholders, and audit follow-up.
  • Continuously improve the effectiveness of existing quality systems and processes by converting quality system related deficiencies identified through audit findings into improved system and process practices.
  • Review and approve corrective action plans and actions as a result of audit findings.
  • Effectively execute and/or follow-up on CAPA (Corrective and Preventive Action) Quality System non-conformance or improvements.
  • Perform all activities in full compliance with quality policies and procedures.
  • Make decisions with some level of oversight.
  • Verify closure of corrective actions and preventive actions from audits.
  • Determine statistical sampling of documents and records to be reviewed during audits.
  • Prepare audit trend reports.
  • Support sites, affiliates, departments, and areas across the business to sustain compliance against applicable standards and regulations.

Oxford is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Oxford will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. Oxford is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. If you need special assistance or an accommodation while seeking employment, please email oxfordbenefits@oxfordcorp.com. We will make a determination on your request for reasonable accommodation on a case-by-case basis.


This job has expired.

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