Internal QA Auditor – Pharmaceuticals

Dallas, TX, US

20 days ago
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Summary

Internal QA Auditor

The Internal QA Auditor is responsible for managing the internal audit program

for the company, which will include auditing our client’s facilities and operations including the Quality Management System, DEA compliance, inventory and records management. The Internal QA Auditor will also assist in other audit activities as needed, such as support and participation in external audits and managing and advising regarding audit remediation planning.

Job Type: Full-time

Responsibilities

  • Develop and lead the internal audit plan, which will include on-site and virtual audits of facilities with the support of the audit team.
  • Develop internal reporting plan for audit results and observations including metrics for internal management reviews.
  • Administrator for the internal audit program within our client’s eQMS.
  • Develop, train and internally certify new employees to participate in the internal audit program.
  • Lead internal meetings regarding audit observations and remediation plans.
  • Other duties as assigned by supervisor.

Experience:

  • 4-year degree highly preferred, such as Bachelors of Science (B.S.)
  • 3-5 years’ experience in pharmaceutical and/or medical device industries preferred
  • 3-5 years' audit experience in an internal or external audit capacity
  • ASQ and or ISO Auditor Certifications required
  • Deftly navigate through Quality and Warehouse Management Systems with training (ComplianceQuest and Tecsys Elite WMS)
  • Intermediate Microsoft Office skills: Outlook, Excel, PowerPoint, Adobe Acrobat
  • Conversant with cGMPs/cGDPs, Quality Systems, DEA (Preferred)
  • Intermediate Technical Writing skills
  • Verifiable aptitude of temperature-controlled warehousing

This position offers a competitive base salary.

Related to: Shipper, Manufacturer, Distributor, Distribution, Fulfillment, Supply Chain, Supply Chain Operations, Distribution Center, Fulfillment Center, Warehouse, Logistics, Refrigerated, Reefer, Temp Controlled, Temperature Controlled, protect from freeze, cold chain, cooling, Quality Assurance, Independent Contributor, Team Player, Individual Contributor, IC

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