Quality Assurance Auditor | cGMP | FDAJoin an industry-leading health and wellness manufacturer dedicated to improving lives through science, innovation, and uncompromising quality. With a strong reputation for excellence, the company develops trusted products backed by research and produced to the highest standards of quality and compliance. Employees enjoy a collaborative, values-driven culture that emphasizes integrity, continuous improvement, professional growth, and making a meaningful impact every day. If you're looking to join a mission-focused organization where quality matters and people are valued, you'll feel right at home here! The Supplier Quality Specialist – Audits & Compliance 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 Supplier Quality Specialist 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.
Experience with 21 CFR Parts 210, 211 and 21 CFR 111ASQ 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
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
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!
