Quality Assurance Specialist-Shift

• Industry Pharma/Biotech/Clinical Research
• City Carlow
• State/Province Carlow
• Country Ireland

Job Description

Quality Assurance Specialist. The role ensures compliance with cGMP, supports production, reviews batch documentation, and maintains quality systems in a sterile manufacturing environment.

Responsibilities

• Work a 4-shift pattern (12-hour shifts).
• Review batch documentation, line clearances, and investigations.
• Respond promptly to unplanned events and technical issues.
• Conduct audit readiness activities and maintain metrics.
• Support spot checks and walk throughs of production lines.
• Investigate customer complaints when required.
• Collaborate cross functionally and act as an active team member.

Reporting Structure: Reports to Quality Manager.

Qualifications

• Bachelor's degree in a science discipline (preferred).
• 1-2 years experience in a quality role at a pharmaceutical manufacturing facility, preferably aseptic.
• Technical knowledge of sterile manufacturing processes.
• Experience with cGMP, GDP, and relevant Irish/EU/International codes.
• Proficiency with MES, SAP, and Trackwise.
• Strong written communication for report, policy and standard preparation.
• Ability to prioritize, manage multiple tasks and meet deadlines.
• Experience in a shift position (12-hour shifts) is beneficial.

Shift Details

Onsite role; 4 shift pattern (12 hour shifts) with varying week schedules.