QC Operations Specialist – Aseptic & Compliance

Astellas; Ireland; On-site; EUR 42,000 - 52,000; Full time

Job summary

Astellas in Ireland is hiring for a QC Operations Support Associate to provide essential GMP QC support in a highly regulated aseptic manufacturing facility in Tralee. The role focuses on line clearance, environmental monitoring, water sampling, and batch review to uphold the facility's CCS and EU GMP standards.

The position requires a B.Sc. in Microbiology or related field and may involve shift work to support manufacturing operations.

Qualifications

• GMP QC experience in a regulated manufacturing setting.
• Structured documentation and data integrity awareness.
• Ability to work in shifts as required.

Responsibilities

• Carry out GMP QC tasks in aseptic manufacturing.
• Perform line clearance and sampling per procedures.
• Support environmental monitoring in Grade C & D areas.
• Review batch records with ALCOA+ principles.
• Assist investigations, CAPAs, and Change Controls.
• Maintain safety and compliance within the facility.

Skills

Organizational Focus

Quality Compliance

Education

B.Sc. degree in Microbiology, Biotechnology or similar field

Job description

Astellas in Ireland is hiring for a QC Operations Support Associate to provide essential GMP QC support in a highly regulated aseptic manufacturing facility in Tralee. The role focuses on line clearance, environmental monitoring, water sampling, and batch review to uphold the facility's CCS and EU GMP standards.

The position requires a B.Sc. in Microbiology or related field and may involve shift work to support manufacturing operations.