QA Aseptic GMP Specialist – Shop Floor Quality Lead

Grifols Shared Services North America, Inc; Dublin; On-site; EUR 60,000 - 90,000; Full time

Benefits offered by this job

Highly competitive salary

Group pension scheme

Private Medical Insurance

Education allowance

Wellness activities

Job summary

Grifols is seeking a QA Manufacturing Specialist - Shop Floor to oversee GMP manufacturing operations in the Albumin production facility. You will partner with Manufacturing, Maintenance, Automation and Quality to ensure safe, compliant production and timely batch release.

You will bring 3+ years in aseptic GMP manufacturing, with experience in deviations, CAPAs and QMS systems. Role involves strong attention to detail, collaboration and driving a quality culture in a Grade A-D cleanroom

Qualifications

• Bachelor in a scientific field is required.
• Minimum 3 years in aseptic GMP manufacturing.
• Experience with deviations, investigations and CAPAs.

Responsibilities

• Provide QA oversight for GMP manufacturing operations.
• Review quality documentation and release readiness.
• Conduct shop floor presence and observations (GEMBA).
• Approve GMP documents including SOPs and batch records.
• Support deviations, investigations, CAPAs and changes.
• Act as QA contact for manufacturing operations.
• Coach teams on GMP and aseptic practices.
• Participate in risk assessments and validations.
• Support inspections and maintain required documentation.
• Contribute to continuous improvement initiatives.

Skills

GMP compliance

Quality oversight

GEMBA walks

Documentation

Organisational skills

Multitasking

Education

Bachelor's degree in a scientific discipline

Tools

Batch Records

LIMS

Veeva Vault

Trackwise

Job description

Grifols is seeking a QA Manufacturing Specialist - Shop Floor to oversee GMP manufacturing operations in the Albumin production facility. You will partner with Manufacturing, Maintenance, Automation and Quality to ensure safe, compliant production and timely batch release.

You will bring 3+ years in aseptic GMP manufacturing, with experience in deviations, CAPAs and QMS systems. Role involves strong attention to detail, collaboration and driving a quality culture in a Grade A-D cleanroom