Quality Specialist

FuseGlobal

United States

Remote

Who this role is best for

Geared toward candidates with industry-specific quality system experience comfortable with specification lifecycle management and cross-functional collaboration. The role emphasizes remote work within the U.S. and aligns with regulated manufacturing environments.

Best fit for

Candidates with 1-3 years of quality system experience in regulated manufacturing environments
— “Minimum of 1-3 years of experience in the food, dietary supplement, medical nutrition, pharmaceutical, nutraceutical, or contract manufacturing industry.”
Individuals who can manage documentation and ensure compliance with U.S. regulatory standards
— “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.”
Professionals with strong communication and data management skills for cross-functional coordination
— “Excellent written and oral communication skills, including the ability to document technical rationale and communicate requirements to contract manufacturers.”

Things to consider

Remote work is mandatory, with candidates required to be located in the United States
— “Remote (candidates must be located in the United States)”
The role may require extended hours or flexible scheduling for urgent updates and compliance
— “When required, ability to work extended hours or flex schedule to support urgent specification updates”

How to stand out

Highlight experience with specification lifecycle management and document control in your resume
— “Familiarity with specification lifecycle management, data integrity, change control, and dietary supplement or food quality system expectations.”
Demonstrate proficiency with quality systems like SAP, Veeva, or PLM during interviews
— “SAP, Veeva, PLM, TraceGains, or comparable quality-system experience preferred.”
Emphasize your ability to create dashboards and reports that improve process visibility
— “Develop dashboards, reports, and routines that improve visibility to overdue updates, compliance gaps, launch risks, and implementation bottlenecks.”
Showcase your understanding of FDA 21 CFR Part 111 and 117 requirements in your application
— “Understanding of FDA 21 CFR Part 111 and 117 requirements and how they translate into finished product, raw material, packaging, and release testing specifications.”
Include examples of managing trackers and structured data reviews using Excel and Office Suite
— “High proficiency with Excel and Office Suite; ability to manage trackers, dashboards, and structured data reviews.”

Pace · SteadyCollaboration · MediumAutonomy · MediumDecision Impact · Team

Derived from job-description analysis by Serendipath's career intelligence engine.

What success looks like

Maintain compliance with applicable safety, environmental, and information-management requirements
Develop dashboards, reports, and routines that improve visibility to overdue updates, compliance gaps, launch risks, and implementation bottlenecks

Typical background

1-3 years of experience with specification management, quality systems, data maintenance, or release testing requirements in SAP, Veeva, PLM, TraceGains, or comparable systems1-3 years of experience in the food, dietary supplement, medical nutrition, pharmaceutical, nutraceutical, or contract manufacturing industry

Skills & requirements

Required

Specification ManagementQuality SystemsData MaintenanceRelease Testing RequirementsSAPVeevaPLMTracegains

Preferred

U.S. Regulatory And Gxp RequirementsFDA 21 CFR Part 111 And 117

Stack & domain

Specification ManagementQuality SystemsData MaintenanceRelease Testing RequirementsSAPVeevaPLMTracegainsComplianceGovernanceCoordinationTrackingExecutionDrivingSupportDevelopmentMaintenanceCreationRoutingClosingEnvironmentalInformation-managementPaperlessEfficientControlledTraceableAudit-readyFoodDietary SupplementMedical NutritionPharmaceuticalNutraceuticalContract ManufacturingRegulatoryQualityFood ScienceChemistryMicrobiologyNutritionSupply ChainTechnical Field

About the role

Original posting from FuseGlobal via Greenhouse

Title: Quality Specialist
Location: Remote (candidates must be located in the United States)
Company: Fortune 100 Food & Beverage Manufacturing (FuseGlobal has worked with this company for 20 years)
Initial term: 6 months (Month Day, Year - Month Day, Year) (position expected to run longer)
Schedule: Mon-Fri 8am to 5pm
About This Role:
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.
What You'll Do:
Compliance and governance
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.
Safety and Environmental
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.
What You Bring:
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.
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.
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.
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.
Compensation & Benefits:
Up to $37.95 per hour + overtime
Medical insurance
Dental insurance
Vision insurance
401(k)
Disability insurance
About FuseGlobal:
FuseGlobal is a partnership of people and brand-leading companies, working together to make things run better. For 25 years we have brought functionality to complex business and production processes and supply chains, resulting in enterprises that run smarter and more sustainably. Interested in digital manufacturing, industrial engineering, supply chain management, all-things tech, and energy & the environment? This is where we live. Engage with us!
#LI-Remote
#LI-FG

Source: FuseGlobal careers (Greenhouse)