QA specialist

Avantor
Netherlands
Workplace: OnsiteFull timeFunction: QA, Test & Release EngineeringExperience: 3+ yearsSkills: ["Communication","Prioritization","Root cause analysis","Problem solving","Multi-tasking"]

Ensure customer and regulatory requirements are met by performing inspections across the production process, including manufacturing, filling, labeling/assembly, and related documentation. Verify GDP/GMP compliance and maintain audit readiness by documenting and trending non-conformances, stopping production for NCMs, and supporting event/complaint investigations. Use root-cause tools (e.g., 5M+E, 5 Whys) to identify and permanently resolve quality issues.

Loading

Loading job details...

Preparing the role view and application actions.

FursaFursa
Avantor
Avantor
1 month ago

QA specialist

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI
Last checked: 24 days agoStatus: Live

Job Summary

Ensure customer and regulatory requirements are met by performing inspections across the production process, including manufacturing, filling, labeling/assembly, and related documentation. Verify GDP/GMP compliance and maintain audit readiness by documenting and trending non-conformances, stopping production for NCMs, and supporting event/complaint investigations. Use root-cause tools (e.g., 5M+E, 5 Whys) to identify and permanently resolve quality issues.
Location: Netherlands
Workplace: Onsite
Employment Type: Full time
Job Function: QA, Test & Release Engineering
Seniority: Mid level

Key Responsibilities

  • •Inspect product and review documentation throughout production to confirm customer and regulatory requirements are met.
  • •Ensure compliance with applicable standards and regulations (e.g., ISO 9001/13485, 21 CFR 820/11), cGMP, and GDP, and help maintain audit readiness.
  • •Perform pre-fill, in-process, and final inspections; determine acceptability of product, components, and documentation.
  • •Stop production for non-conformance (NCM), document NCMs, and document and trend quality production issues.
  • •Provide event and complaint investigation support and use root-cause tools (e.g., 5M+E, 5 Whys) to resolve issues.

Key Requirements

  • •High school completion (or equivalent/GED) with at least 3 years of related experience and/or training in a regulated industry; or a bachelor’s degree.
  • •Experience in a Quality Assurance role within the medical device, biotech, or pharmaceutical industry (preferred).
  • •Knowledge of ISO 9001, ISO 13485, 21 CFR 820, 21 CFR 11, ISO 17025, or EXCiPACT (preferred).
  • •Demonstrated experience/knowledge conducting root cause analysis for non-conforming material investigations.
  • •Ability to balance multiple tasks and prioritize efficiently; good communication skills.
Experience:3+ yearsRegulated industryMedical devicesBiotechPharmaceuticals
Skills:CommunicationPrioritizationRoot cause analysisProblem solvingMulti-tasking
Tech Stack:ISO 9001ISO 1348521 CFR 82021 CFR 11ISO 17025EXCiPACTCGMPGDPMicrosoft OutlookMicrosoft WordMicrosoft ExcelMicrosoft Access5M+E5 Whys

Company Brief

Avantor
Provides mission-critical products and services to support life sciences, advanced technologies, and applied materials customers worldwide, including lab supplies, chemical reagents, equipment, and supply chain solutions.
Industry: Wholesale & Distribution
Company Size: Enterprise (1,001+ employees)
Revenue: USD 1B+
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: Radnor, United States
WebsiteLinkedIn