Avantor

19 hours ago

QA specialist

✓ Verified Job

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

Source: Company careers pageValidated by: Fursa AI

Last checked: 19 hours 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

Website LinkedIn

Loading job details...

Preparing the role view and application actions.

Avantor

19 hours ago

QA specialist

✓ Verified Job

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

Source: Company careers pageValidated by: Fursa AI

Last checked: 19 hours agoStatus: Live

Job Summary

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

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

Website LinkedIn