Quality Assurance Auditor jobs in United States
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McKesson · 1 day ago

Quality Assurance Auditor

McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. As a Quality Assurance Auditor, you will support the global audit program, ensuring compliance with FDA regulations and current Good Manufacturing Practices through audits and collaboration with suppliers.

BiopharmaBiotechnologyHealth CareInformation TechnologyPharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Execute audit program activities to ensure all audits are completed on schedule
Perform full audits of vendor manufacturing facilities for compliance with FDA regulations and cGMP
Document findings and collaborate with suppliers to address corrective actions
Travel extensively (50%–75%) to supplier sites, primarily domestic with some international
Support continuous improvement of audit processes
Maintain accurate audit records and reports
Collaborate with internal stakeholders to ensure quality and compliance objectives are met

Qualification

CGMPFDA regulationsISO 13485Medical device auditingProject managementMicrosoft Office SuiteSpanish bilingualCommunicationDetail-oriented

Required

Bachelor's degree in Science or related field
2+ years in medical device or pharmaceutical auditing, or quality assurance in a regulated environment
Experience performing cGMP audits of manufacturers
Strong understanding of cGMP, 21 CFR 820, ISO 13485
Excellent communication skills (written and verbal)
Detail-oriented with ability to follow procedures
Proficiency in Microsoft Office Suite

Preferred

Project management experience preferred
Spanish bilingual strongly preferred

Benefits

Eligible for annual bonus and comprehensive benefits

Company

McKesson

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McKesson distributes medical supplies, information technology, and care management products and services.

H1B Sponsorship

McKesson has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (149)
2024 (129)
2023 (82)
2022 (142)
2021 (144)
2020 (154)

Funding

Current Stage
Public Company
Total Funding
unknown
1994-11-18IPO

Leadership Team

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Brian Tyler
CEO
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Jim McAuliffe
CFO
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Company data provided by crunchbase