QA Manufacturing Specialist

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

Position Summary

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment.

The QA Manufacturing Specialist - Shop Floor is responsible for providing quality oversight and guidance for GMP manufacturing operations within the Albumin production facility. The successful candidate will partner closely with Manufacturing, Maintenance, Automation, and Quality teams to ensure the safe and compliant production of Albumin products. Key responsibilities include supporting day-to-day manufacturing operations, reviewing and resolving quality issues, facilitating product release activities, and promoting a strong culture of quality and compliance. As a subject matter expert in GMP compliance, the QA Specialist will provide coaching and guidance to operational teams while ensuring adherence to industry regulations and aseptic manufacturing standards. A solid understanding of sterile manufacturing requirements, including EU GMP Annex 1 and aseptic processing principles within Grade A-D cleanroom environments, is essential for success in this role.

What You Will Do

• Provide QA oversight for GMP manufacturing operations, ensuring compliance with cGxP, EU Annex 1, FDA, and internal quality standards.
• Support batch release readiness through timely review and completion of quality documentation.
• Conduct shop floor presence activities, including GEMBA walks and manufacturing observations, to maintain GMP compliance and inspection readiness.
• Review, approve, and author GMP documentation, including SOPs, batch records, risk assessments, and training records.
• Support deviations, investigations, CAPAs, change controls, and continuous improvement initiatives.
• Act as the primary QA contact for manufacturing operations, providing guidance on quality, compliance, and aseptic processing activities.
• Drive quality culture by coaching and supporting Manufacturing, Maintenance, and Quality teams on GMP, contamination control, and aseptic best practices.
• Participate in risk assessments, validation activities, media fills, smoke studies, and contamination control initiatives.
• Support internal and external inspections and maintain inspection-ready documentation.
• Contribute to operational improvement and project activities to enhance quality, compliance, and manufacturing performance.

What You Will Bring

• Minimum Bachelors degree in a scientific discipline.
• Minimum 3 years' experience in aseptic manufacturing within a Quality or Manufacturing capacity in a GMP-regulated environment, preferably utilizing RABS technology (Grade A & B) is a requirement.
• Working experience with QMS processes, both paper-based and electronic systems (e.g., Batch Records, LIMS, Veeva Vault, Trackwise, etc.)
• Understanding of GMP regulation and guidance, notably Annex 1 'Sterile Manufacture' and FDA Aseptic Guide.
• Working experience with deviations, Investigations, and CAPAs.
• Strong organisational and coordination ability
• High attention to detail and accuracy under pressure
• Ability to multitask and manage shifting priorities effectively
• Proactive and solution-oriented mindset

Our Benefits Include

• Highly competitive salary
• Group pension scheme - Contribution rates are
• Private Medical Insurance for the employee
• Ongoing opportunities for career development in a rapidly expanding work environment
• Succession planning and internal promotions
• Education allowance
• Wellness activities - Social activities eg. Golf, Padel, Summer Event

We understand that self-doubt can hold talented individuals back from applying for opportunities.

Location

Grange Castle International Business Park, Grange, Co. Dublin, D22 K2R3 ( more about Grifols

Type

Regular Full-Time

Job Category

Quality