Quality Assurance Auditor

Quality Assurance Auditor at Masis Professional Group Quality Assurance Auditor at Masis Professional Group in Charlotte, North Carolina Posted in 2 days ago.

Type:

full-time

Job Description:

???? Quality Assurance Auditor | 30-45 minutes of Charlotte, NC ???? US Citizens or Green Card Holders only | No C2C ????? M-F 8:30am - 5:00pm The Quality Assurance Auditor reports to the Supplier Quality and Compliance Manager. This role is responsible for developing and maintaining a strong Internal Compliance program ensuring compliance to applicable regulations. The QAA is required to perform internal and external audits, prioritize audit schedules and corrective actions to the findings identified. ?

Must-Haves:

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 travel 20 - 30% for domestic audits, (International travel may be needed per quality management). ??

What You'll Do:

Plan, schedule, and conduct internal and external audits to ensure regulatory and quality compliance. Audit suppliers and contract manufacturers (CMOs) and maintain vendor qualification programs. Manage supplier corrective actions (SCARs) and verify effective CAPA i mplementation. Assess audit findings, determine risk levels, and drive corrective and preventive actions. Maintain audit, supplier, and compliance documentation within the Quality Management System (QMS). Monitor and report audit and compliance metrics to management. Train and support cross-functional teams on quality and compliance requirements. Identify compliance risks and support process improvements to mitigate risk. Support regulatory inspection readiness and ongoing compliance initiatives. Utilize SAP and electronic quality systems to support Quality Assurance activities.

Preferred:

? ASQ Certified Quality Auditor (CQA) preferred. ? SAP and Quality Management System experience .? Outstanding Benefits & Relocation Package! ? 45 Days of Fully Furnished Temporary Housing $5,000 Relocation Stipend Paid Area Exploration Visits Weekly Pay Christmas Eve-New Year's Shutdown Up to $5,000 Annual Tuition Reimbursement Gym/Fitness Reimbursement Company-Paid Life Insurance Company-Paid Short-Term Disability Employee Assistance Program (EAP) Annual HSA Contribution Daycare & Private School Tuition Assistance ? A company that truly invests in its employees and their families! ?