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Quality Specialist
Job Location:
Job Location:
Albany, GA - USA
Monthly Salary:
Not provided by the employer
Monthly Salary:
Posted:
29 September 2026 (2 days ago)
Posted:
Application Deadline:
27 December 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
Summary:
McKesson is seeking a Quality Specialist with experience in Healthcare Pharmaceutical Medical Device or Regulated Distribution environments to support Quality Management System (QMS) operations supplier quality programs quality agreements SOP development and regulatory compliance activities.
The ideal candidate will have strong knowledge of FDA 21 CFR Part 211 ISO 13485 supplier quality processes and document-controlled QMS environments.
Roles & Responsibilities:
McKesson is seeking a Quality Specialist with experience in Healthcare Pharmaceutical Medical Device or Regulated Distribution environments to support Quality Management System (QMS) operations supplier quality programs quality agreements SOP development and regulatory compliance activities.
The ideal candidate will have strong knowledge of FDA 21 CFR Part 211 ISO 13485 supplier quality processes and document-controlled QMS environments.
Roles & Responsibilities:
- Support Quality Management System (QMS) activities and regulatory compliance initiatives.
- Manage customer and supplier quality questionnaires and supplier qualification processes.
- Review and support Quality Agreements supplier contracts and compliance documentation.
- Author revise and maintain SOPs and controlled quality documents.
- Support controlled substance compliance processes and regulatory requirements.
- Ensure alignment with FDA DEA ISO 13485 and internal quality standards.
- Maintain audit-ready documentation and records following ALCOA principles.
- Collaborate with Quality Regulatory Operations Legal and Compliance teams.
- 35 years of experience in Quality Compliance QA or Regulated Distribution environments.
- Experience in Pharmaceutical Medical Device Healthcare or Life Sciences industries.
- Knowledge of FDA 21 CFR Part 211 and/or ISO 13485 requirements.
- Experience with Supplier Quality Quality Agreements and Quality Questionnaires.
- Experience authoring and maintaining SOPs.
- Experience working within a document-controlled QMS environment.
- Strong technical writing documentation and audit support skills.
- DEA Controlled Substance compliance experience.
- Experience supporting supplier/customer audits.
- Experience with MasterControl or other eQMS platforms.
- ASQ CQE CQA or related certifications.
Required Experience:
IC
