Audit Supervisor

Job Description:

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.

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

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