QA Manufacturing Support & Batch Documentation Specialist

AGC Biologics A/S; København; On-site; DKK 420,000 - 560,000; Full time

Job summary

AGC Biologics A/S in Søborg is seeking a QA Manufacturing Support Technician to join the bridge between QA and Manufacturing. You will help ensure GMP compliant documentation during solution preparation and support batch release activities near the production line.

The role combines hands-on production support with document review, emphasizing GDP and Good Documentation Practice. Strong English communication and team collaboration are essential for daily operations.

Qualifications

• Bachelor's degree or technician qualification in production.
• GMP/GLP experience in biopharma preferred.
• Experience reviewing Batch Production Records and Solution Preparation Sheets.
• Fluent written and spoken English; good communication.

Responsibilities

• QA oversight in the Solution Preparation production suite.
• Review and answer questions on batch documentation (GDP).
• Review and approve Buffer and Media Batch Production Records.
• Print Batch Process Records and manage manufacturing labels.
• Provide real-time review of manufacturing records and logbooks.
• Assist with scanning, archiving and related tasks as needed.

Skills

QA oversight

Documentation review

Batch records

Communication

Collaboration

Education

Bachelor's degree (BSc) or Technician in production

Job description

AGC Biologics A/S in Søborg is seeking a QA Manufacturing Support Technician to join the bridge between QA and Manufacturing. You will help ensure GMP compliant documentation during solution preparation and support batch release activities near the production line.

The role combines hands-on production support with document review, emphasizing GDP and Good Documentation Practice. Strong English communication and team collaboration are essential for daily operations.