Associate Specialist QA

About the role

The Associate Specialist QA acts as a quality expert, applying Johnson & Johnson's Quality Systems to create, review and approve GMP documentation for commercial products at our manufacturing site. The role collaborates closely with Operations, QC, MAM, MSAT and other quality departments.

Key responsibilities

• Review and approve routine GMP documentation, including batch release records, raw material and drug substance releases, and related SAP tags.
• Approve maintenance notifications, work orders and SAP‑PM master data changes, as well as calibration documents.
• Perform quality reviews of periodic review reports and provide oversight of validated utilities, equipment and processes.
• Support local and global improvement initiatives as a subject‑matter expert and participate in internal audits and inspections.

Required profile

• BSc or MSc in a science or business‑related field with 2‑4 years of experience in a GMP‑regulated pharmaceutical environment.
• Strong knowledge of Quality Management principles, GMP, Quality Systems and pharma regulations.
• Excellent written and verbal communication skills in English; Dutch is a plus.
• Analytical thinking, problem‑solving and decision‑making capabilities.

Required skills

• GMP documentation review and approval
• SAP (including SAP‑PM and SAP tags)
• Quality Management Systems (QMS)
• Aseptic processing techniques and sterile manufacturing requirements

What we offer

• Base salary range €38,300 – €61,410 per year
• Annual performance bonus
• Generous vacation, parental, bereavement, caregiver and volunteer leave
• Well‑being reimbursement and health programs covering physical, mental and financial health
• Service anniversary and recognition awards, plus eligibility for various insurance plans