Quality Assurance Auditor

QA Auditor

Lancaster, SC

Full-Time, Permanent

Roles and Responsibilities

• Manage audit planning, scheduling, and execute internal and external audits to assess compliance to the regulations.
• Audit external suppliers (CMO’s) and maintain the vendor qualification program including the Approved Vendor List in Qualityze
• Manage external vendor(s) responsible for international audits
• Manage supplier corrective action request program (SCAR).
• Manage all documents relating to audits, vendors, and suppliers in a QMS (Qualityze)
• Determine the level of risk of findings identified and follow up on corrective actions ensuring they address the short-term correction as well as the preventive action of the finding.
• Develop and implement a performance tracking system and reporting of departmental compliance.
• Prioritize work to ensure that audits and reports are completed in a timely manner. Support implementation of CAPA program where necessary.
• Train and assist internal departments to understand and comply with Quality and Compliance expectations.
• Assess internal audit process by identifying and prioritizing areas of the business where there is a risk of non-compliance and assist in development and/or execute processes or 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 with all levels of the organization and departments within the organization and function within a team environment.
• Understand the roles and responsibilities of the Contract Manufacturing Organizations and provide Quality Assurance support for product development, investigations, and CAPAs as required.
• Familiar with QA functions in SAP.
• Perform other assigned duties as may be required in meeting Quality Assurance and company objectives.

Minimum Requirements

• Must have a minimum of 5 years of Quality Assurance auditing experience in cGMP environment with a minimum of 5 years of external vendor/ supplier compliance auditing experience within an FDA regulated industry.
• Knowledge of the Regulations 21CFR Part(s) 210, 211, 507 as well as the Dietary Supplement Regulations 21 CFR 111 is required.
• ASQ Certified Auditor (CQA) Certification is preferred.
• Must be proficient in Computer Software applications including MS office suite.
• Must be able to stand, walk, push, and pull in a variety of environments including a Manufacturing and clean rooms.
• Must have the ability to wear all required Personal Protective Equipment (PPE) based on the auditing environment.
• Must be able to travel 20 – 30% for domestic audits, (International travel may be needed per quality management).

Education and Experience

B.A. or B.S. in Science or Technical field required.