Audit Supervisor

THE RITEDOSE CORPORATIONColumbia, SC
Onsite

About The Position

The Audit Supervisor supports the internal audit program, supplier quality management activities and coordination/execution of customer and regulatory audits. This role is responsible for overseeing day-to-day audit activities, ensuring compliance, and guiding audit team members.

Requirements

  • Bachelors’ degree in Pharmacy, Chemistry, Biology or related field
  • 3-5 years’ experience in the pharmaceutical manufacturing industry with a quality background
  • Working knowledge of cGMP/ 21CFR regulations
  • Experience supporting FDA or regulatory audits
  • Proficient with word processing and database software

Nice To Haves

  • ASQ Certified Quality Auditor (CQA), or ability to obtain certification within 12 months of hire

Responsibilities

  • Support execution of internal audits according to the Internal Audit Master Plan
  • Monitor and follow up on corrective action implementation related to audit findings
  • Assist in the oversight of the supplier quality management process
  • Conduct supplier audits, including on-site inspections when required
  • Maintain records of audits performed and assist in scheduling repeat audits
  • Support coordination and tracking supplier quality alerts
  • Participate in regulatory and customer audits and assist with audit readiness activities
  • Perform trending of audit findings and report opportunities for improvement to management
  • Maintain current knowledge of applicable regulations and guidance documents
  • Provide guidance and day-to-day direction to audit team members
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