QC Specialist Microbiologie at GE Healthcare

Eindhoven, North Brabant, Netherlands

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Radiopharmaceuticals, Medical Imaging, HealthcareIndustries

Requirements

HBO/WO werk- en denkniveau in Life Sciences (Chemie, Biochemie, Microbiologie)
Relevante ervaring met QC-analyses in een farmaceutische GMP-omgeving
Grondige kennis van en ervaring met microbiologische technieken en kwaliteitsnormen
Kennis van apparatuurkwalificaties, methodevalidaties en statistische analysetools
Affiniteit met QC-software, data integrity en LEAN-methodieken
Sterke communicatieve en organisatorische vaardigheden
Uitstekende beheersing van Nederlands en Engels in woord en schrift
Competenties: Proactief en analytisch; Resultaat- en oplossingsgericht; Zelfstandig en een teamspeler

Responsibilities

Ondersteunen van QC en site brede (CAPEX) projecten op het gebied van microbiologie
Ondersteunen van de operationele microbiologie afdeling op het gebied van microbiologische testen (bioburden, endotoxine, steriliteits testen, environmental monitoring, MALDI-TOF t.b.v identificatie), troubleshooting, methode validaties, trendreview, oorzaak analyse
Beheren van Change Controls en CAPA’s
Ontwikkelen en optimaliseren van analysemethoden (bijv. steriliteitstesten)
Schrijven van protocollen en rapportages voor projecten, kwalificaties en methodevalidaties
Coördineren van microbiologische methodevalidaties
Onderzoeken en oplossen van afwijkingen en risico’s op het gebied van veiligheid, data integrity en GMP
Signaleren en implementeren van verbeteringen in processen en best practices
Ondersteunen van operationele teams bij systeem- en analyseproblemen
Beoordelen van regelgeving en Pharmacopeia-wijzigingen en opvolgen van acties
Uitvoeren van statistische trendanalyses en bepalen van correctieve acties
Leiden of ondersteunen bij OOS/OOT-onderzoeken en audits
Trainen en coachen van collega’s op microbiologische processen

Skills

Key technologies and capabilities for this role

MicrobiologieBioburdenEndotoxineSteriliteits testenEnvironmental MonitoringMALDI-TOFMethode validatieTroubleshootingTrendreviewOorzaak analyseChange ControlsCAPAQC projecten

Questions & Answers

Common questions about this position

Is remote work possible in this role?

Yes, a hybrid setup where you can also work from home is possible.

What education and experience are required for this position?

The role requires an HBO/WO level in Life Sciences such as Chemistry, Biochemistry, or Microbiology, along with relevant experience in QC analyses in a pharmaceutical GMP environment.

What key microbiological skills are needed?

Proficiency in microbiological testing including bioburden, endotoxine, sterility testing, environmental monitoring, and MALDI-TOF for identification is required, along with thorough knowledge of microbiological techniques and quality standards.

What is the salary or compensation for this role?

This information is not specified in the job description.

What makes a strong candidate for this QC Specialist role?

Candidates with HBO/WO in Life Sciences, hands-on GMP experience in QC microbiology, and skills in method validation, troubleshooting, change controls, and coaching colleagues stand out.

GE Healthcare

Healthcare technology and data analytics provider

About GE Healthcare

GE Healthcare provides a range of healthcare technologies and services aimed at improving patient care. Its main products include imaging systems, mobile diagnostic devices, patient monitoring solutions, and advanced software for data analysis. These products help medical professionals make informed decisions and enhance the efficiency of healthcare delivery. Unlike many competitors, GE Healthcare invests significantly in research and development, allocating $1 billion each year to innovate and enhance its offerings. The company’s goal is to support healthcare providers in delivering better patient outcomes, as evidenced by its technology supporting over 300,000 patients daily and managing 2 billion patient scans each year.

Chicago, IllinoisHeadquarters

1892Year Founded

N/ACompany Stage

Data & Analytics, HealthcareIndustries

10,001+Employees

Risks

Emerging AR technologies increase competition in medical imaging.

Regulatory challenges may delay AI application expansions in healthcare.

Dependence on clinical trial success for new product market positioning.

Differentiation

GE Healthcare invests $1 billion annually in R&D for product innovation.

The company supports over 300,000 patients daily with its healthcare technologies.

GE Healthcare's AIR Recon DL offers 3D motion-insensitive imaging for enhanced MRI quality.

Upsides

Acquisition of Caption Health expands AI-powered ultrasound capabilities.

Successful Phase III trial of [18F]flurpiridaz enhances coronary artery disease detection.

Collaboration with Wayra accelerates digital health innovation in EMEA.

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