Onsite Specialist II, Scientific Support

Avantor; Leiden; On-site; EUR 60,000 - 70,000; Full time

Job summary

Avantor is seeking a Non-Conformance Investigator (QC) to lead and document investigations into quality incidents in a GMP-regulated environment. You will identify root causes, assess risks, and implement CAPAs to prevent recurrence across QC and QA.

Qualifications

• Degree in Life Sciences, Chemistry, Pharmacy, or related field.
• Experience in GMP-regulated pharmaceutical or biotechnology environment.
• Knowledge of deviation management, CAPA, OOS investigations, and quality systems.

Responsibilities

• Investigate QC deviations, OOS/OOT results, and non-conformance events.
• Perform root cause analyses using tools such as Fishbone, 5 Whys, and trend analysis.
• Assess the impact of quality events on products, processes, and compliance.
• Develop and track CAPAs to completion.
• Prepare clear and accurate investigation reports.
• Support regulatory inspections and internal audits.
• Identify recurring issues and recommend process improvements.
• Ensure investigations are completed within defined timelines and quality standards.

Skills

GMP experience

Root cause analysis

CAPA knowledge

Technical writing

Education

Bachelor's in Life Sciences/ Chemistry/ Pharmacy

Job description

The Opportunity

Carries out a range of complex scientific support tasks at customer facilities, requiring significant interpretation of technical/scientific protocols to support research objectives effectively. Solves intricate research support and technical challenges independently, drawing on a deep understanding of laboratory techniques, experimental design, and past experiences to inform judgments and decisions. Supports nucleic acid workflows, performs DNA/RNA extraction and preparation for sequencing, and/or maintains and expands cell and tissue cultures, supporting R&D and production workflows. Collects, documents, and organizes data and observations, ensuring clarity and accessibility for review and analysis by research teams. Collaborates extensively with internal scientific support teams and customer contacts, facilitating communication and understanding across disciplines to meet customer's needs.

Non-Conformance Investigator (QC)

The Non-Conformance Investigator is responsible for leading and documenting investigations related to quality incidents and other non-conformances within the Quality Control department. The role focuses on identifying root causes, assessing product and compliance risks, and implementing effective corrective and preventive actions (CAPAs) to prevent recurrence. The investigator collaborates closely with QC analysts, QA, manufacturing, and other stakeholders to ensure timely closure of investigations and compliance with GMP regulations.

Key Responsibilities

• Investigate QC deviations, OOS/OOT results, and non-conformance events.
• Perform root cause analyses using tools such as Fishbone, 5 Whys, and trend analysis.
• Assess the impact of quality events on products, processes, and compliance.
• Develop and track CAPAs to completion.
• Prepare clear and accurate investigation reports.
• Support regulatory inspections and internal audits.
• Identify recurring issues and recommend process improvements.
• Ensure investigations are completed within defined timelines and quality standards.

Qualifications

• Degree in Life Sciences, Chemistry, Pharmacy, or a related field.
• Experience in a GMP-regulated pharmaceutical or biotechnology environment.
• Knowledge of deviation management, CAPA, OOS investigations, and quality systems.
• Strong analytical, problem-solving, and technical writing skills.

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.

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 [e-mail] 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.

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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. 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. One of our greatest strengths comes from having a global infrastructure that is strategically located to support the needs of our customers. 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.