Document Control Specialist — QMS & Compliance

Aerogen; Galway; Hybrid; EUR 45,000 - 65,000; Full time

Benefits offered by this job

Excellent medical care

Bonus & Pension

Aerogen Connect program

Job summary

Aerogen, headquartered in Galway, Ireland, is seeking a Document Control System Administrator to manage and improve the control of documents across the organisation. The role focuses on processing required changes, coordinating workflows, and capturing key metrics to support quality management and regulatory compliance.

The ideal candidate will have 2+ years in document control or quality administration, experience with document management systems, and a solid understanding of ALCOA++ and ISO

Qualifications

• Diploma or Bachelor's Degree in Business Administration, Quality, Information Management, or related discipline.
• 2+ years' experience in a document control, quality administration, or records management role.
• Experience working with document management systems and Microsoft Office applications.
• Strong understanding of document control principles (ALCOA++), version control, and records management.
• A good understanding of EN ISO 13485, MDSAP, MDR, QMSR requirements.

Responsibilities

• Maintain the organization's document control system and ensure all controlled documents are accurately recorded.
• Manage document creation, review, approval, revision, distribution, and archival processes.
• Ensure only current approved versions of documents are available for use.
• Maintain indexing, filing, and retrieval systems.
• Facilitate document updates and revisions with document owners and departmental stakeholders.
• Archive obsolete documents in accordance with retention requirements.
• Monitor document review schedules and facilitate the periodic reviews process.
• Assist with change control processes associated with quality management systems.

Skills

Document control

Attention to detail

Multitasking

Communication skills

Independent & collaborative

Education

Bachelor's Degree in Business Admin/Quality

Tools

Microsoft Office

Document management systems

Job description

Aerogen, headquartered in Galway, Ireland, is seeking a Document Control System Administrator to manage and improve the control of documents across the organisation. The role focuses on processing required changes, coordinating workflows, and capturing key metrics to support quality management and regulatory compliance.

The ideal candidate will have 2+ years in document control or quality administration, experience with document management systems, and a solid understanding of ALCOA++ and ISO