Metric Bio are currently partnered with a leading nutraceutical organization in South Carolina who are looking for a Quality Assurance Auditor, to report to the Director of Quality and is responsible for maintaining an Internal Compliance program to ensure regulatory adherence. This includes conducting internal and external audits, prioritizing audit schedules, and overseeing corrective actions.
Key Responsibilities:
Manage audit planning, scheduling, and execution for facilities in South Carolina and Maryland, including audits of external suppliers.
Assess risk levels of findings and oversee corrective actions, focusing on both short-term corrections and preventive measures.
Develop and implement performance tracking and compliance reporting systems.
Prioritize tasks to ensure timely completion of audits and reports.
Provide support for CAPA program implementation and regulatory inspections readiness.
Train internal departments on Quality and Compliance standards.
Evaluate and prioritize areas of business risk and assist in developing processes to mitigate non-compliance.
Support Quality Assurance teams in South Carolina and Maryland.
Report audit metrics to management and collaborate effectively across departments.
Understand and support Contract Manufacturing Organizations' Quality Assurance requirements.
Review CMO batch records and assist with in-house batch release.
Manage international audit vendors and the supplier corrective action request program (SCAR).
Minimum Requirements:
Minimum 5 years of Quality Assurance auditing experience in cGMP environments, with 5 years in external vendor/supplier compliance auditing within FDA-regulated industries, or 10 years of related GMP experience.
Familiarity with FDA Regulations (21CFR Part(s) 210, 211, 507) and Dietary Supplement Regulations (21 CFR 111).
Ability to travel 20-30% domestically (with potential for international travel) and work in various environments, including manufacturing and clean rooms, wearing required Personal Protective Equipment (PPE).
Education
B.A. or B.S. in Science or Technical field
Should this sound like an opportunity that would match your background and location requirements, we would like to connect with you, to discuss further. Feel free to contact me directly or apply using the posting.
Please note: due to a large volume of expected applicants, only those who meet the above requirements will be contacted.