Associate Specialist Quality Assurance

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.

We provide an inclusive work environment where each person is considered as an individual.

At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:
Quality

Job Sub Function:
Quality Assurance

Job Category:
Business Enablement/Support

All Job Posting Locations:
Leiden, Netherlands

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements.

Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Job Description

The Associate Specialist QA serves as a quality subject matter expert responsible for ensuring GMP compliance throughout the introduction and lifecycle management of products within the manufacturing environment.

Working closely with Operations, Quality Control, Engineering, and Development teams, the role supports quality systems, batch release activities, documentation management, change control processes, and compliance initiatives.

The Associate Specialist QA plays a critical role in maintaining product quality, supporting regulatory compliance, driving continuous improvement, and fostering a strong quality culture across the organization.
Key Responsibilities


* Perform electronic batch record reviews and support batch disposition activities in accordance with GMP requirements.


* Review and release raw materials while maintaining accurate material master data within quality systems.


* Assess, approve, and verify change controls to ensure compliance and effective implementation of process changes.


* Review and approve GMP documents, including master batch records, validation reviews, and shipment-related documentation.


* Prepare release packages for Qualified Persons (QP) and support product release processes.


* Participate in local and global quality projects, support process optimization initiatives, and promote a culture of quality and compliance throughout the organization.

Requirements


* Bachelor's degree or higher in Biochemistry, Biology, Pharmacy, Life Sciences, or a related s...