Quality Specialist

FuseGlobal

2d•Remote

About The Position

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. The position ensures specification updates are aligned with approved formulas, label claims, product release requirements, microbiological and contaminant standards, market-specific requirements, and contract manufacturer capabilities. Drives specification compliance, data integrity, and continuous improvement under the direction of Contract Manufacturing Quality Leadership.

Requirements

Minimum of 1-3 years of experience with specification management, quality systems, data maintenance, or release testing requirements in SAP, Veeva, PLM, TraceGains, or comparable systems.
Minimum of 1-3 years of experience in the food, dietary supplement, medical nutrition, pharmaceutical, nutraceutical, or contract manufacturing industry.
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.
Excellent written and oral communication skills, including the ability to document technical rationale and communicate requirements to contract manufacturers.
High proficiency with Excel and Office Suite; ability to manage trackers, dashboards, and structured data reviews.

Nice To Haves

Knowledge of U.S. regulatory and GxP requirements applicable to Nutrition & Health products, including 21 CFR Part 111, 21 CFR Part 117, HACCP, HARPC, and product release controls preferred.
Bachelor’s degree or equivalent experience in Quality, Food Science, Regulatory, Chemistry, Microbiology, Nutrition, Supply Chain, or a related technical field preferred.
SAP, Veeva, PLM, TraceGains, or comparable quality-system experience preferred.
When required, ability to work extended hours or flex schedule to support urgent specification updates, launch readiness, regulatory requests, release holds, or contract manufacturer implementation needs.

Responsibilities

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/material, contract manufacturer, system status, and implementation date.
Coordinate specification updates with contract manufacturers to confirm feasibility, testing capability, method alignment, COA 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.
Other specification quality duties may be assigned as required.
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.