Quality Assurance Auditor

Overview of the Role

The position involves maintaining and evolving an effective Internal Compliance program to ensure adherence to relevant standards. Responsibilities include conducting internal and external audits, organizing audit schedules, and addressing any identified issues through corrective actions.

Duties and Obligations

• Coordinate audit planning, scheduling, and execution of internal and external audits to evaluate compliance with industry regulations.

• Conduct audits on external suppliers and oversee the vendor qualification process.

• Supervise external vendors conducting international audits.

• Manage the supplier corrective action request system.

• Maintain all documentation related to audits, vendors, and suppliers.

• Assess the risk levels of identified findings and ensure appropriate corrective actions are taken to address immediate and long-term concerns.

• Develop and implement a system for tracking performance and reporting departmental compliance.

• Prioritize tasks to ensure timely completion of audits and reports, and provide support for program implementations.

• Offer training and guidance to internal departments on Quality and Compliance standards.

• Evaluate internal audit processes to identify areas of non-compliance risk and collaborate on developing processes or policies to mitigate those risks.

• Assist in preparing for regulatory inspections and support other team members in Quality Assurance.

• Share audit metrics with Quality Assurance and departmental management, and engage effectively with various organizational levels and departments.

• Understand and support the roles of Contract Manufacturing Organizations in product development and investigations.

• Fulfill any other duties assigned to meet Quality Assurance and company goals.

Qualifications

• Minimum 5 years of Quality Assurance auditing experience in a cGMP environment and 5 years of external vendor/supplier compliance auditing in an FDA regulated sector.

• Knowledge of Regulations 21CFR Part(s) 210, 211, 507, and 21 CFR 111 for Dietary Supplements is mandatory.

• Preferred ASQ Certified Auditor (CQA) Certification.

• Proficiency in MS Office applications is required.

• Ability to stand, walk, push, and pull in various environments, including Manufacturing and clean rooms.

• Capability to wear necessary Personal Protective Equipment (PPE) as per auditing environment requirements.

• Travel up to 20 – 30% for audit purposes.

Education and Background:

• B.A. or B.S. in a Science or Technical field is essential.