Associate Specialist Quality Assurance

jj; Leiden; On-site; EUR 38,000 - 61,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Bereavement leave

Well-being reimbursement

Job summary

Johnson & Johnson Leiden is seeking an Associate Specialist QA to ensure GMP compliance across the product lifecycle in a manufacturing environment. You will collaborate with Operations, Quality Control, Engineering, and Development to uphold quality systems and regulatory standards.

The role focuses on batch release, documentation management, and continuous improvement while fostering a strong quality culture across the organization. English proficiency is essential; Dutch is a plus.

Qualifications

• Bachelor’s degree or higher in Biochemistry, Biology, Pharmacy, Life Sciences, or a related scientific discipline.
• Minimum of 2 years of experience in a GMP-regulated environment within Quality Assurance or related function.
• Strong understanding of GMP regulations, quality systems, batch release, and change control.

Responsibilities

• Perform electronic batch record reviews and support batch disposition activities per GMP requirements.
• Review and release raw materials while maintaining accurate material master data in 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 and support process optimization initiatives.

Skills

English

Quality assurance

Regulatory compliance

Documentation

Dutch language (nice to have)

Education

Bachelor’s degree in Life Sciences

Job description

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

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 scientific discipline.
• Minimum of 2 years of experience in a GMP-regulated environment within Quality Assurance, Quality Control, Manufacturing, or a related pharmaceutical/biotechnology function.
• Strong understanding of GMP regulations, quality systems, batch release processes, change control, and compliance requirements.
• Experience within the biotechnology or pharmaceutical industry; knowledge of gene therapy and biological products is considered an advantage.
• Excellent analytical, problem-solving, and decision-making skills, with strong attention to detail and the ability to work independently.
• Strong communication, influencing, and stakeholder management skills, with excellent written and verbal English; Dutch language skills are a plus.

Required Skills:

Preferred Skills:

Accountability, Administrative Support, Compliance Management, Detail-Oriented, Document Management, Execution Focus, Goal Attainment, Human-Centered Design, Internal Controls, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Report Writing

The anticipated base pay range for this position is:

€38.300,00 - €61.410,00

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.