Sr Quality Specialist, Distribution

McKesson•Ellabell, GA

13h

About The Position

McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve – we care. What you do at McKesson matters. We foster a culture where you can grow, make an impact, and are empowered to bring new ideas. Together, we thrive as we shape the future of health for patients, our communities, and our people. If you want to be part of tomorrow’s health today, we want to hear from you. Job Description The Senior Quality Assurance Specialist provides senior‑level quality oversight for Regional Distribution Center (RDC) operations and plays a critical role in ensuring compliance with FDA regulations, McKesson’s Quality Management System (QMS), and customer expectations. This role performs and approves product disposition activities, supports import and FDA-facing interactions, executes computer system validation (CSV) tasks, and partners with operations and cross-functional teams to drive consistent quality execution across the network.

Requirements

4+ years of relevant experience
Strong understanding of FDA regulations applicable to distribution operations.
Demonstrated experience with product inspection, release, hold processes, and quarantine activities.
Working knowledge of import compliance and support for regulatory inspections or audits.
Hands-on experience with CSV activities for GxP systems.
Solid understanding of data integrity principles and electronic records requirements.
Ability to work independently and exercise sound quality judgment in fast-paced, high-stakes environments.
Strong written, verbal, and interpersonal communication skills.
Proven ability to collaborate cross‑functionally and manage competing priorities.
Excellent attention to detail with strong documentation and organizational skills.
Bachelor’s degree required; STEM strongly preferred
Proficiency in Microsoft Word, Outlook, and Excel.

Nice To Haves

Training or experience in FDA‑regulated distribution, import compliance, or CSV is preferred.

Responsibilities

RDC Quality Operations & Product Disposition Provide senior‑level quality oversight for RDC operations to ensure compliance with FDA regulations, QMS requirements, and customer standards.
Inspect, review, and release product for distribution in alignment with approved procedures and specifications.
Place product on quality hold or quarantine when nonconformances, damage, regulatory concerns, or data integrity issues arise.
Perform and approve product disposition decisions, including release, rework, rejection, or destruction, ensuring complete documentation and traceability.
Oversee and support: Incoming, in‑process, and outbound inspections Product destruction reconciliation
FDA-Facing & Import Quality Support Serve as a primary quality contact for FDA import activities, including resolving import holds, exams, and information requests.
Coordinate documentation required for product admissibility and partner with Quality Management, Trade Compliance, Operations, and external partners.
Support inspection readiness and interact directly with FDA investigators during RDC inspections or follow‑up activities.
Escalate regulatory or import‑related issues promptly and support related investigations.
Computer System Validation (CSV) & Data Integrity Serve as an SME for CSV activities involving WMS, ERP, eQMS, labeling systems, inspection systems, and other GxP computerized systems.
Execute, review, and approve CSV lifecycle documentation, including: Risk assessments and validation plans IQ/OQ/PQ (or equivalent) testing Validation summary reports and traceability matrices
Provide quality oversight for computerized system change controls, ensuring proper risk assessment, validation, regression testing, and documentation.
Perform and support data integrity activities, including: User access reviews and re‑certifications Verification of system outputs (labels, reports, electronic records) Identification and escalation of data integrity risks
Regional & Cross‑Functional Support Provide quality support to multiple RDCs within the network as needed.
Partner with Operations, IT, and Quality teams to ensure consistent quality processes and expectations across sites.
Lead or contribute to regional quality projects, remediation activities, and continuous improvement initiatives.
General Responsibilities Participate in and/or lead quality workstreams for site and regional initiatives.
Maintain flexibility to support extended hours, holidays, or weekends as required.
Travel as needed to support RDC operations, audits, or regulatory activities.
Perform additional Quality Assurance responsibilities as assigned.