Evening Change Control Specialist: ISO/GMP & 20% Shift

Dexcom Inc.; Athenry; On-site; EUR 41,000 - 53,000; Full time

Benefits offered by this job

Front row seat to CGM tech learning

Comprehensive benefits program

Global growth opportunities

Career development program

Job summary

Dexcom is hiring a Document Control Specialist 3 in Ireland to sustain the change control system and support all document control activities in line with 21 CFR Part 820 and ISO-13485. Proficiency in Microsoft Office and reporting is required; critical thinking and issue resolution skills are essential.

The role operates on a fixed evening shift pattern (3:30 PM - 12 Midnight) with a 20% shift allowance. Typically 4–6 years of related experience and an NFQ level 6 diploma or equivalent are

Qualifications

• NFQ level 6 diploma or equivalent is required.
• 4-6 years related experience in document control or QA.
• Understanding of GDP and GMP guidelines.

Responsibilities

• Manage the change control system and release change orders.
• Assist in training for change control software and related processes.
• Ensure projects are completed accurately and on time.
• Interact with internal and external customers and audits.
• Monitor document changes and revisions to deadlines.
• Scan, archive and retrieve quality documents and records.
• Issue controlled and uncontrolled documents and maintain service records.
• Prepare reproduction requests and support SOPs updates.
• Support testing and improvement of change control software.

Skills

Microsoft Office Suite

Report generation

Critical thinking

Documentation systems

GDP and GMP knowledge

Rotating shift flexibility

Education

NFQ level 6 diploma or equivalent

4-6 years related experience

Job description

Dexcom is hiring a Document Control Specialist 3 in Ireland to sustain the change control system and support all document control activities in line with 21 CFR Part 820 and ISO-13485. Proficiency in Microsoft Office and reporting is required; critical thinking and issue resolution skills are essential.

The role operates on a fixed evening shift pattern (3:30 PM - 12 Midnight) with a 20% shift allowance. Typically 4–6 years of related experience and an NFQ level 6 diploma or equivalent are