Onsite Specialist II, Scientific Support

Avantor Sciences; Leiden; Presencial; EUR 60 000 - 90 000; Tempo integral

Resumo da oferta

Avantor in Leiden, Netherlands seeks a motivated Non-Conformance Investigator (QC) to join its Quality Control team. You will lead investigations into deviations, CAPAs, and OOS/OOT events, assessing risks and regulatory impact while collaborating with QA, manufacturing, and technical staff.

The role requires GMP experience in pharma/biotech, strong analytical and writing skills, and proficiency with root-cause tools such as Fishbone and 5 Whys.

Qualificações

• Degree in Life Sciences, Chemistry, Pharmacy, or 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.

Responsabilidades

• Investigate QC deviations, OOS/OOT results, and non-conformance events.
• Perform root cause analyses using 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.

Conhecimentos

Deviation management

CAPA process

OOS investigations

Quality systems

Analytical thinking

Technical writing

Formação académica

Life Sciences / Chemistry / Pharmacy degree

Descrição da oferta de emprego

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.

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.

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.

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.