Technical Specialist Quality and Compliance

Leiden , South Holland, Netherlands

Type: n/a

Category: IT & Internet & Media

Requirements: English
Company: NLwerkt
Region: Leiden , South Holland

Bedrijfsomschrijving

Join our team and help shape the future of healthcare. Apply today and become part of a company thats not just leading the industry but also changing lives around the world.

Why YACHT?

Because of challenging positions at leading companies, a large network and development opportunities! These are the advantages of working via YACHT.

With us, you will get all the space to grow further. Together we will look for assignments that suit your ambitions and help you to realize your goals. Through coaching, for example, but also by inviting you to interesting courses, knowledge sessions and inspiring meetings.

Through us, you will get access to a large network of professionals and companies that are happy to share their knowledge and opportunities with you.

Functieomschrijving

Join Janssen Biologics B.V. , one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and become part of a world-leading organization dedicated to the development, production, and marketing of vaccines and antibodies to combat infectious diseases.

At our Leiden site ,As a Technical Specialist , you will be the driving force behind quality and compliance in our laboratory operations. Youll manage medium- and high-priority compliance issues, lead investigations, and serve as the subject matter expert during audits and product transitions. Youll also play a pivotal role in maintaining cGMP compliance, leading continuous improvement projects, and guiding your team with safety, compliance, and reliability as your core values.

Key Responsibilities:

• Lead investigations for deviations and non-conformances, coordinating corrective and preventive actions (CAPAs).
• Act as Subject Matter Expert (SME) during audits and inspections.
• Serve as the single point of contact (SPOC) for new product introductions, lab investigations, and equipment qualifications.
• Own and manage technical systems related to (analytical) lab equipment.
• Review and update lab documentation, particularly in support of new product introductions (NPIs).
• Provide hands-on technical support and collaborate with local/global customers and service teams.
• Champion and lead continuous improvement (LEAN) initiatives.
• Foster strong communication and trusted relationships with lab technicians, cross-functional teams, and leadership.

Functie-eisen

Were looking for a detail-oriented, technically strong individual who can independently handle complex lab quality challenges while actively contributing to a high-performance, collaborative environment.

• Bachelors degree (HLO) or higher in Life Sciences , Molecular Biology , or related fields.

• Proficient in English (written & verbal).

• Demonstrated ability to work independently and within cross-functional teams.

• Experience with microbiological techniques (e.g., bioburden, endotoxin, sterility) is highly preferred.

• Analytical mindset with strong technical problem-solving skills.

• Prior GMP experience is a plus.

Arbeidsvoorwaarden
What We Offer:

• Flexible working hours
• Opportunities to work on exciting projects with real impact
• A collaborative, inclusive, and inspiring workplace
• Global career development pathways and educational support
• Competitive salary and benefits package
• Being part of a purpose-driven, diverse, and motivated team

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