Supplier Quality Auditor

Supplier Quality Auditor at Entegee Supplier Quality Auditor at Entegee in Great Falls, South Carolina Posted in 10 days ago.

Type:

full-time

Job Description:

Supplier Quality Auditor We are seeking an experienced Supplier Quality Auditor to support and ensure compliance across external suppliers and internal quality systems within an FDA-regulated environment. This role is critical to maintaining cGMP compliance and driving continuous improvement across our supplier network. The ideal candidate brings deep expertise in FDA regulations, hands-on auditing experience, and the flexibility to conduct supplier audits with limited notice. Relocation Assistance Provided! No Visa Sponsorships Supplier Quality Auditor Job Responsibilities Plan, conduct, and report internal and external quality audits in accordance with cGMP and FDA requirements Perform supplier and vendor compliance audits , including qualification, surveillance, and requalification audits Evaluate supplier quality systems against FDA regulations and applicable quality standards Identify compliance gaps, issue audit findings, and track corrective and preventive actions (CAPAs) Partner cross-functionally with Quality, Regulatory, Operations, and Supply Chain teams Maintain audit documentation and ensure readiness for regulatory inspections Stay current on FDA regulatory changes and industry best practices Supplier Quality Auditor Job Qualifications Minimum 5 years of Quality Assurance auditing experience in a cGMP environment Proven experience auditing external vendors/suppliers within an FDA-regulated industry Strong working knowledge of FDA regulations, including: 21 CFR Part 210

• Basic GMP requirements for drug manufacturers 21 CFR Part 211
• GMP for finished pharmaceutical products 21 CFR Part 507
• Manufacturing and safety requirements for animal food 21 CFR Part 111
• GMP for dietary supplement manufacturers Direct experience conducting both internal and external audits Ability to travel to supplier sites with limited notice Excellent written, verbal, and interpersonal communication skills Experience auditing multiple product categories (pharmaceutical, dietary supplement, animal health, etc.

) Familiarity with supplier risk management and continuous improvement programs Certifications such as CQA, ASQ, or equivalent (a plus)

Job Disclaimer:

Equal Opportunity Employer/Veterans/Disabled Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria.

Disclaimer:

These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/ The Company will consider qualified applicants with arrest and conviction records.