Supplier Quality Auditor (Great Falls)
Entegee, Great Falls, SC, United States
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.
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.