Quality Auditor - Manufacturing

Quality Auditor – Supplier Quality & Manufacturing

Our client is actively seeking an experienced Quality Auditor with a strong foundation in manufacturing quality and supplier qualification. This is an excellent opportunity for someone who understands what happens on the manufacturing floor and can evaluate how quality decisions impact product, compliance, and business risk. This is not a desk-only auditing position. The ideal candidate is hands-on, comfortable working directly with manufacturing and supplier environments, and confident making risk-based quality decisions.

Location

Onsite daily in Lancaster, SC

First shift hours

M-F, 8:30 - 5pm EST

Salary range

$70-$95k; may be negotiable based on education, experience, geo location and other factors

Role

• Lead and support the supplier qualification and approval program, with approximately 70% of the role focused on supplier quality/external compliance.
• Qualify and oversee raw material suppliers, packaging suppliers, CMOs, contract laboratories, and third-party audit organizations.
• Conduct supplier, CMO, and contract laboratory audits.
• Manage and coordinate third-party auditing resources.
• Evaluate supplier quality issues and make informed, risk-based decisions.
• Support and assess deviations, investigations, CAPAs, non-conformances, and risk assessments.
• Work closely with manufacturing and quality teams to understand the potential impact of quality decisions on production and product quality.
• Help strengthen supplier-management processes and QMS workflows.

Requirements

• Bachelor's degree in a science, engineering, technical, or related discipline.
• 5 years of QA auditing experience in a cGMP environment & external vendor/supplier compliance within an FDA regulated industry.
• Knowledge of Regulations 21CFR Par(s) 210, 211, 507 as well as the dietary supplements regulations, 21 CFR.
• Must have experience with internal & external auditing.
• Must have the flexibility to travel to suppliers for audits with limited notice.
• Strong experience with supplier qualification, supplier quality, and auditing.
• Experience auditing or qualifying raw material suppliers is highly desired.
• Experience working with CMOs, packaging suppliers, and contract laboratories.
• Solid knowledge of CAPA, deviations, investigations, non-conformances, supplier quality, and risk assessment.
• Experience in an FDA-regulated manufacturing environment.
• Background in pharmaceuticals, dietary supplements, nutraceuticals, life sciences, or animal health is strongly preferred.

Travel - approximately 20–30% travel, domestic

Benefits offerings may include but are not limited to:

Medical

Dental

Vision

Vacation/401k

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

· The California Fair Chance Act

· Los Angeles City Fair Chance Ordinance

· Los Angeles County Fair Chance Ordinance for Employers

· San Francisco Fair Chance Ordinance