QA Auditor

Job Overview:

Search Solution Group is seeking a Quality Assurance Auditor on behalf of our client, a respected leader in the research, development, and manufacturing of medical products for people and pets. This role plays a vital function in maintaining compliance with regulatory standards, ensuring the quality and safety of products through systematic audits, supplier oversight, and adherence to cGMP and FDA regulations.

Key Responsibilities:

Plan and conduct internal and external audits to ensure ongoing compliance with regulatory requirements.

Audit external suppliers (Contract Manufacturing Organizations - CMOs) and manage vendor qualification within the Qualityze system.

Oversee third-party vendors executing international audits.

Administer and manage the Supplier Corrective Action Request (SCAR) program.

Maintain and organize audit and vendor records in the Quality Management System (QMS).

Evaluate audit findings, define risk levels, and monitor follow-up corrective and preventive actions.

Develop and report on audit performance metrics and departmental compliance data.

Ensure timely completion of audit reports and support CAPA (Corrective and Preventive Action) initiatives.

Train internal departments on quality standards and compliance protocols.

Identify compliance risks and support mitigation strategies.

Assist in regulatory inspection readiness and participate in quality investigations.

Collaborate cross-functionally with internal departments to ensure quality goals are achieved.

Provide quality support for product development and CAPA processes related to CMOs.

Use SAP systems to manage QA-related tasks.

Perform other quality assurance tasks as needed to support organizational objectives.

Requirements include:

Education:

Bachelor's degree in a science or technical field (BA/BS required)

Experience:

Minimum 5 years of QA auditing experience in a cGMP and FDA-regulated environment

At least 5 years of experience auditing external vendors or suppliers

Skills:

Strong attention to detail and ability to evaluate compliance risks effectively

Proficiency in Microsoft Office Suite

Experience with QMS platforms, preferably Qualityze

Ability to analyze data, manage multiple priorities, and communicate clearly

Familiarity with SAP QA modules is a plus

Certifications:

ASQ Certified Quality Auditor (CQA) is preferred but not required

Knowledge:

Solid understanding of U.S. FDA regulations, including 21 CFR Parts 210, 211, 507, and 111

Familiarity with best practices in auditing, vendor management, and CAPA processes

Key Competencies:

Strong organizational and documentation skills

Critical thinking and risk assessment abilities

Effective verbal and written communication

Collaboration and cross-functional teamwork

Analytical mindset with a focus on continuous improvement

Ability to manage time effectively and meet audit deadlines

How to Apply:

To apply for this position, please click the "Apply" button at the top right of your screen. Alternatively, you can email your application to . Please ensure to include your resume and any other relevant documents or information that showcase your qualifications and suitability for the role. We appreciate your interest in joining our team and look forward to reviewing your application.

Company Overview:

Company Industry: Packaging and Containers

Location: Fort Mill, SC Equal Opportunity Employer Statement:

Search Solution Group is an Equal Opportunity Employer committed to fostering an inclusive workplace where diversity is valued and respected. We do not discriminate on the basis of race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status in our hiring process or employment practices. We believe that a diverse workforce brings unique perspectives and strengths, driving innovation and growth. All employment decisions are based on qualifications, merit, and business needs. We welcome applicants from all backgrounds to apply and contribute to our team.

Disclaimer:

Please note that the job description provided is not exhaustive and is subject to change. Additional duties may be assigned as needed to meet the evolving needs of the organization and to ensure the successful completion of projects and objectives.