Audit Supervisor

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

Qualifications

• 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
• ASQ Certified Quality Auditor (CQA), or ability to obtain certification within 12 months of hire
• Experience supporting FDA or regulatory audits
• Proficient with word processing and database software