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American Nitrile · 1 month ago

QA Specialist III

Grove City, OH

Full-time

Onsite

Mid, Senior Level

$26/hr - $30/hr

3+ years exp

American Nitrile is focused on ensuring the highest quality in nitrile glove manufacturing. The QA Specialist III plays a crucial role in maintaining compliance with FDA regulations and internal protocols, overseeing quality testing, inspections, and continuous improvement efforts to ensure product integrity.

Health CareManufacturingMedicalMedical Device

Responsibilities

Conduct routine inspections of raw materials, in-process gloves, and finished goods, including packaging and palletized shipments

Perform glove-specific in-process QA testing (e.g., dimensions, water-leak testing, and visual defect inspection) in accordance with applicable ASTM standards and internal procedures

Maintain ALCOA+-compliant documentation for all sampling, testing, and inspection activities

Ensure compliance with FDA, ISO 13485, ASTM standards, customer specifications, and internal quality protocols

Identify, document, and investigate non-conformances (e.g., glove defects, packaging errors, palletizing issues)

Conduct root-cause analysis and support creation/implementation of CAPAs

Escalate significant issues to the Quality Assurance Manager

Maintain accurate electronic records of inspections, sampling plans, AQL results, pallet verifications, and deviations

Generate daily QA summaries, trend reports (defect rates, failure modes), and Certificates of Analysis (CoAs) for shipments

Ensure data integrity and traceability

Train and mentor QA technicians and packaging/palletizing personnel on inspection methods, defect recognition, sampling procedures, and safety

Assign tasks, monitor performance, and support competency development for QA staff

Assist with onboarding and qualification of new employees

Work with Production, Engineering, Supply Chain, and Warehouse teams to: Improve glove inspection accuracy and consistency

Strengthen packaging and pallet quality controls

Reduce defects and waste through structured problem solving

Resolve material or packaging discrepancies

Lead initiatives to improve QA processes, sampling plans, and testing efficiency

Enforce safety protocols and ensure clean, organized QA and packaging support areas

Calibrate/maintain QA equipment (water-leak fixtures, thickness gauges, dimension gauges)

Manage QA consumables, sampling tools, and retention sample inventory

Qualification

FDA regulations complianceGMP standards knowledgeAQL sampling expertiseQuality inspection experienceCAPARCA toolsAdvanced Excel skillsISO certification knowledgeBilingual (English/Spanish)Leadership abilitiesAttention to detailOrganizational skills