Quality Assurance Specialist
CR/079254
Posted: 24/09/2025
- Competitive
- Ireland, County Carlow, Carlow
- Contract
Orion Group Life Sciences are currently recruiting a Quality Assurance Specialist (Shift) on behalf of our Multinational Biopharmaceutical Client based in Carlow on an 11-Month contract.
This is a shift position – 4 cycle 12 hours per shift
Role Overview
The Quality Assurance Specialist is required to:
Additional Responsibilities
Qualifications & Experience
Education
Experience
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
This is a shift position – 4 cycle 12 hours per shift
- Week 1- long week: Monday – Tuesday Days, Friday, Sat, Sun nights
- Week 2- short week: Wed and Thurs Days,
- Week 3: Long week: Monday – Tuesday nights, Friday, Sat and Sun Days
- Week 4: short week: Wednesday and Thurs Nights
- Shift premium is 33%
Role Overview
The Quality Assurance Specialist is required to:
- Work a 4-shift pattern role
- Possess technical knowledge of sterile manufacturing processes
- Perform timely reviews of batch documentation, investigations, and reports, highlighting and assisting in the resolution of concerns commensurate with risk
- Respond quickly to unplanned events and technical issues
- Demonstrate operational experience with quality systems in a dynamic manufacturing environment (e.g. SAP, Trackwise, MES)
- Have a full understanding of relevant quality and compliance regulations, including knowledge of requirements for cGMP and both US and EU regulatory standards
- Conduct, report, and display Quality Right First Time and audit readiness metrics weekly to ensure continuous audit readiness and cGMP compliance
- Support the spot check and walk-through processes of production lines
- Participate in customer complaint investigations as required
Additional Responsibilities
- Provide Quality support to production teams to ensure cGMP standards are consistently maintained
- Understand sterile manufacturing operations (preferred)
- Learn and utilize computerized systems to perform daily tasks
- Prioritize and manage multiple tasks to meet defined deadlines
- Review batch documentation (e.g. Electronic Batch Records), perform line clearances, and assist in resolving concerns
- Liaise with other departments to promote improvements in GMP and Quality standards
- Comply with all relevant Quality and EHS Management System requirements as applicable to commercial operations
Qualifications & Experience
Education
- Bachelor’s Degree or higher preferred in a Science discipline
Experience
- 1–2 years' experience in a Quality role within a pharmaceutical manufacturing environment, preferably sterile/aseptic manufacturing
- Experience using systems such as SAP, MES, and Trackwise (desirable)
- Strong technical writing and documentation skills
- Working knowledge of applicable Irish, European, and international codes, standards, and practices
- Solid understanding of cGMP and GDP requirements
- Competency in the use of MES and SAP systems
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
Aoibhinn Daly
Recruitment Consultant
Apply for this role
Recruitment