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Location: Lancaster, SC | Schedule: Full-time, on-site

Overview

An established manufacturer in a regulated industry is seeking a Quality Assurance Auditor to build and maintain a strong internal compliance program. This role is central to ensuring the organization meets applicable regulatory standards through rigorous internal and external auditing, risk assessment, and corrective action management.

What you'll do

• Manage audit planning, scheduling, and execution of internal and external audits to assess regulatory compliance
• Audit external suppliers and maintain the vendor qualification program
• Manage the external vendor responsible for international audits
• Manage the supplier corrective action request program
• Manage all documentation relating to audits, vendors, and suppliers
• Determine risk levels of audit findings and follow up on corrective actions, ensuring both short-term correction and preventive action
• Develop and implement a performance tracking and reporting system for departmental compliance
• Prioritize work to ensure audits and reports are completed in a timely manner; support program implementation as needed
• Train and assist internal departments in understanding and meeting Quality and Compliance expectations
• Assess the internal audit process by identifying and prioritizing areas of business risk, and help develop or execute processes/policies to reduce that risk
• Support training and readiness for regulatory inspections
• Provide support to other Quality Assurance team members
• Report audit metrics to Quality Assurance and department management
• Communicate effectively across all levels and departments of the organization within a team environment
• Understand the roles and responsibilities of Contract Manufacturing Organizations and provide Quality Assurance support for product development and investigations as required
• Perform other duties as needed to meet Quality Assurance and company objectives

Required qualifications

• Minimum of 5 years of Quality Assurance auditing experience in a cGMP environment
• Minimum of 5 years of external vendor/supplier compliance auditing experience within an FDA regulated industry
• Knowledge of Regulations 21CFR Part 210, 21CFR Part 211, and 21CFR Part 507, as well as Dietary Supplement Regulations 21 CFR 111
• Proficiency in computer software applications, including MS Office suite
• Ability to stand, walk, push, and pull in a variety of environments, including manufacturing and clean rooms
• Ability to wear all required Personal Protective Equipment (PPE) based on the auditing environment
• Ability to travel 20 – 30% for audits
• B.A. or B.S. in Science or a Technical field required

Preferred qualifications

• ASQ Certified Auditor (CQA) Certification preferred

Why this role

This position offers the opportunity to build and lead a compliance program that ensures adherence to critical FDA regulations while working across teams and with external partners in a regulated manufacturing environment.