QA Specialist III - Grove City, OH,
3 days ago
Job description
The QA Specialist 3 ensures compliance with FDA regulations (21 CFR Part 820), GMP standards, ISO/ASTM requirements, and internal protocols by overseeing in-process and finished-goods quality testing for nitrile glove manufacturing. This role is responsible for inspections, sampling, AQL testing, packaging and pallet quality verification, and generation of Certificates of Analysis (CoAs). The QA Specialist 3 supports continuous improvement, maintains product integrity, and ensures compliance across production and packaging operations.
Duties and Responsibilities
- Quality Control & Compliance
- 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.
- Non-Conformance & Corrective Action Management
- 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.
- Data Management & Reporting
- 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.
- Team Leadership & Training
- 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.
- Process Improvement & Cross-Functional Collaboration
- 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.
- Work with Production, Engineering, Supply Chain, and Warehouse teams to:
- Safety, Equipment, & Inventory
- 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
Qualifications
- High School Diploma required; ASQ, ISO, or Six Sigma certifications preferred.
- 3+ years in FDA-regulated manufacturing (medical devices/nitrile gloves preferred).
- 1+ year in a leadership or supervisory capacity.
- Experience in glove or product quality inspection, QA sampling, and packaging/pallet QC.
- Strong knowledge of GMP, 21 CFR 820, AQL sampling, and ASTM glove standards.
- Skilled in physical glove testing (dimensions, water-leak, visual inspection).
- Proficiency with CAPA, RCA tools, and quality documentation.
- Advanced Excel/Office 365 skills for analysis and reporting.
- Bilingual (English/Spanish) preferred.
- High attention to detail for inspections, documentation, and defect detection.
- Strong organizational skills for managing multiple priorities (sampling, testing, audits).
- Excellent communication and leadership abilities.
- Flexibility during audits, investigations, and peak production.
Working Conditions
- Physical Demands: Frequent standing, walking, bending, and lifting up to 25lbs for sampling and inspections.
- Environment: Fast-paced manufacturing and warehouse settings; includes non-temperature-controlled packaging and palletizing areas.
- Schedule: Occasional overtime during high-volume production, audits, or critical shipping periods.
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