- Naleven van bedrijfsbeleid, procedures, werkinstructies en opleidingsvereisten, met focus op klantenservice, productie en kwaliteit.
- Rekening houden met klantbelangen en wettelijke vereisten. Ervoor zorgen dat aan de behoeften van klanten wordt voldaan door ordervereisten, documentatie-eisen, correcte vul- en assemblagevereisten te controleren en, waar nodig, andere technici te begeleiden in het volgen van de gedocumenteerde VWR Solon-procedures en GMP-richtlijnen.
- Zorgen dat:
- Aan klantvereisten wordt voldaan.
- Beleid, procedures en werkinstructies worden nageleefd.
- Documentatie en fysieke producten correct worden gescheiden en niet-conform materiaal dat tijdens het productieproces wordt geïdentificeerd, wordt geïsoleerd en beheerst.
- Productiedocumentatie wordt gecontroleerd op nauwkeurigheid, volledigheid en naleving van GDP-richtlijnen (Good Documentation Practices).
- Problemen met orders worden gecorrigeerd en dat de genomen acties passend zijn.
- Problemen en aandachtspunten worden gecommuniceerd aan de proceseigenaar en direct leidinggevende.
- Het werkgebied voortdurend in een staat van "audit readiness" verkeert.
- Uitvoeren van inspectietaken volgens vastgestelde werkinstructies en procedures, met gebruik van de vereiste hulpmiddelen, methoden en apparatuur om de acceptatie van producten, componenten en documentatie te beoordelen.
- Uitvoeren van pre-fill-, in-process- en eindinspecties aan de hand van gedocumenteerde werkinstructies en inspectie-informatie.
- De productie stopzetten wanneer een afwijking (Non-Conformance Material, NCM) wordt vastgesteld en de juiste NCM-procedures volgen.
- Afwijkingen documenteren volgens de geldende VWR Solon-procedures en werkinstructies.
- Kwaliteitsproblemen die tijdens inspecties worden vastgesteld documenteren en analyseren op trends.
- Zorgen voor netheid en orde van de werkplekken tijdens inspectieprocessen.
- Gebruikmaken van probleemoplossingsmethodieken zoals 5M+E, de 5 Why's of andere oorzaakanalysemethoden om problemen te identificeren en duurzaam op te lossen.
- Werken volgens het kwaliteitsmanagementsysteem (QMS) van VWR Solon en het bedrijfsbeleid.
- Aanwezig zijn op de werkvloer om te observeren, medewerkers te trainen en veranderingen te ondersteunen en faciliteren.
- Andere toegewezen taken uitvoeren.
- Afgeronde middelbare schoolopleiding of gelijkwaardig diploma (GED) én minimaal 3 jaar relevante ervaring en/of opleiding binnen een gereguleerde sector; of
- Een bachelordiploma.
- Ervaring in een Quality Assurance-functie binnen de medische hulpmiddelen-, biotech- of farmaceutische sector is een pluspunt.
- Vloeiende beheersing van Nederlands en Engels.
- In staat om meerdere taken tegelijk te beheren en efficiënt prioriteiten te stellen.
- Kennis van ISO 9001, ISO 13485, 21 CFR 820, 21 CFR 11, ISO 17025 of de EXCiPACT-norm is een pluspunt.
- Aantoonbare ervaring of kennis van root cause analysis (oorzaakanalyse) met betrekking tot onderzoeken naar niet-conform materiaal.
- Kennis van en ervaring met Microsoft Outlook, Word, Excel en Access of vergelijkbare softwarepakketten.
- Goede communicatieve vaardigheden.
- Een uitdagende functie binnen een klantgerichte organisatie in een internationale werkomgeving.
- Een aantrekkelijk salarispakket inclusief bonus en andere extralegale voordelen.
- Je komt terecht in een bedrijf dat zijn medewerkers waardeert en hun interne ontwikkeling stimuleert.
- Je werkt op onze nieuwe locatie in Hillegom, waar je de kans krijgt om initiatief te nemen en mee te bouwen aan een nieuw hoofdstuk in het succes van Avantor.
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Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.
Why Avantor?
Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.
The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor.
We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today!
EEO Statement:
We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.
If you need a reasonable accommodation for any part of the employment process, please contact us by email at [email protected] and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
Privacy Policy:
We will use the personal information that you have submitted to us in order to consider your application for the relevant role.
Your privacy is important to us. Please click here for our Privacy Policy which explains the purposes for which we will use your personal information and the ways in which we will handle and retain your information. It also explains the rights you have in relation to your information, and how to contact us with any queries or requests.
3rd Party Non-Solicitation Policy:
By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation.
Skills Required
- High school diploma or GED and minimum 3 years related experience/training in a regulated industry
- Bachelor's degree
- Experience in a Quality Assurance role within medical device, biotech, or pharmaceutical industry
- Knowledge of ISO 9001, ISO 13485, 21 CFR 820, 21 CFR 11, ISO 17025, EXCiPACT
- Demonstrated experience or knowledge conducting root cause analysis for non-conforming material investigations (e.g., 5 Why's, 5M+E)
- Proficiency with Microsoft Outlook, Word, Excel, and Access
- Good communication skills and ability to balance multiple tasks/prioritize
Avantor Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Avantor and has not been reviewed or approved by Avantor.
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Healthcare Strength — Core medical coverage, wellness resources, and an Employee Assistance Program are characterized as solid, with insurance often seen as competitive. Day-one eligibility in some roles and localized wellness programs for associates and families reinforce perceived healthcare value.
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Retirement Support — The 401(k) program provides a company match with immediate vesting and a range of investment options, standing out as a strong savings feature. An employee stock purchase plan and profit-sharing elements further bolster long-term financial benefits.
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Parental & Family Support — Enhanced family-building benefits include paid parental leave, fertility/IVF support, and expanded gender-affirming coverage. These inclusive policies provide meaningful support for caregivers and families.
Avantor Insights
What We Do
Avantor®, a Fortune 500 company, is a leading global provider of mission-critical products and services to customers in the biopharma, healthcare, education & government, and advanced technologies & applied materials industries. Our portfolio is used in virtually every stage of the most important research, development and production activities in the industries we serve. Our global footprint enables us to serve more than 225,000 customer locations and gives us extensive access to research laboratories and scientists in more than 180 countries. We set science in motion to create a better world. More than 13,500 strong, our associates are passionate about our mission to set science in motion to create a better world. We share enthusiasm for innovation, excellence, and achievement. Whether we are collaborating with our customers to advance science or solve multifaceted problems, we help them reach their goals more efficiently and effectively. Visit our website to learn more about Avantor. From FORTUNE. © 2021 FORTUNE Media IP Limited All rights reserved. Used under license. FORTUNE is a registered trademark of FORTUNE Media IP Limited and is used under license. FORTUNE and FORTUNE Media IP Limited are not affiliated with and do not endorse products or services of, Avantor.
