Associate Specialist Quality Assurance

Leiden Bio Science Park; Leiden; On-site; EUR 55,000 - 72,000; Full time

Job summary

Leiden Bio Science Park is seeking an Associate Specialist QA to ensure GMP compliance across product introductions and lifecycle management in our manufacturing environment. You will work with Operations, Quality Control, Engineering and Development to support quality systems, batch release activities and compliance initiatives.

You will perform electronic batch record reviews, assess change controls, review GMP documents and prepare release packages for Qualified Persons, contributing to a

Qualifications

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

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.

Skills

GMP knowledge

Quality Systems

Batch Release

Change Control

Documentation Management

Regulatory Compliance

Education

Bachelor's degree or higher in Biochemistry, Biology, Pharmacy, Life Sciences

Job description

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.

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