Quality Specialist

The Quality Specialist supports U.S. Nutrition & Health contract manufacturing quality by coordinating, tracking, and executing updates to finished product testing specifications for externally manufactured products. This role ensures that specification updates align with approved formulas, label claims, product release requirements, microbiological and contaminant standards, market-specific requirements, and contract manufacturer capabilities. The position drives specification compliance, data integrity, and continuous improvement under the direction of contract manufacturing quality in a remote, full-time capacity.

• Coordinate, track, and execute updates to finished product testing specifications for externally manufactured Nutrition & Health products.
• Maintain specification update activities in alignment with applicable U.S. regulations, quality management system requirements, brand standards, and agreed contract manufacturer controls.
• Create, route, track, and close specification update records, change controls, intake requests, and related tasks in the applicable system of record.
• Maintain a master tracker for U.S. Nutrition & Health contract manufacturing specification updates, including priority, owner, affected SKU or material, contract manufacturer, system status, and implementation date.
• Coordinate specification updates with contract manufacturers to confirm feasibility, testing capability, method alignment, certificate of analysis format, release criteria, and effective-date readiness.
• Support updates related to microbiological requirements, contaminant limits, allergens, claims, certifications, net content, packaging requirements, shelf life, and market-specific criteria.
• Maintain controlled specification records, supporting rationale, approval evidence, and contract manufacturer alignment documentation in SharePoint or the applicable quality system.
• Develop dashboards, reports, and routines that improve visibility to overdue updates, compliance gaps, launch risks, and implementation bottlenecks.
• Perform other specification quality duties as assigned to support overall contract manufacturing quality objectives.
• Maintain compliance with applicable safety, environmental, and information-management requirements when handling controlled documents, records, samples, or contract manufacturer information.
• Support paperless and efficient specification workflows where possible, while ensuring records remain controlled, traceable, and audit-ready.
• Flex work hours or work extended hours when required to support urgent specification updates, launch readiness activities, regulatory requests, release holds, or contract manufacturer implementation needs.

• Minimum of 13 years of experience with specification management, quality systems, data maintenance, or release testing requirements in SAP, Veeva, PLM, Trace Gains, or comparable systems.
• Minimum of 13 years of experience in the food, dietary supplement, medical nutrition, pharmaceutical, nutraceutical, or contract manufacturing industry.
• Knowledge of U.S. regulatory and GxP requirements applicable to Nutrition & Health products, including FDA 21 CFR Part 111, FDA 21 CFR Part 117, HACCP, and product release controls (preferred).
• Understanding of FDA 21 CFR Part 111 and 117 requirements and how they translate into finished product, raw material, packaging, and release testing specifications.
• Familiarity with specification lifecycle management, data integrity, change control, document control, and dietary supplement or food quality system expectations.
• Quality assurance experience, including quality control, GMP, QMS, and audit support.
• Project management skills to manage multiple specification updates, priorities, and timelines.
• Excellent written and oral communication skills, including the ability to document technical rationale and communicate requirements clearly to contract manufacturers.
• High proficiency with Microsoft Excel and Office Suite, with the ability to manage trackers, dashboards, and structured data reviews.
• Experience using SAP, Veeva, PLM, Trace Gains, or comparable quality systems (preferred).

• Bachelors degree or equivalent experience in Quality, Food Science, Regulatory, Chemistry, Microbiology, Nutrition, Supply Chain, or a related technical field (preferred).
• Ability to interpret and apply U.S. regulatory and GxP requirements to Nutrition & Health product specifications and…