QC Technician
Ireland, Ireland / North Europe / Full Time
About CAI:
CAI is a 100% employee-owned company established in 1996, that has grown year over year to nearly 700 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.
Are You Ready?
Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.
As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:
- We act with integrity,
- We serve each other,
- We serve society,
- We work for our future.
With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude. That is how we have grown exponentially.
CAI agents will be exposed to cutting edge technologies in the advanced medicine space. You will have an opportunity to work with recognized subject matter experts allowing YOU to be a key player in bringing lifesaving therapies to market. As part of our company culture, we invest in YOUR future, and commit to hands on certifications as well as professional training. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.
Requirements include:
We are now seeking a Quality Control IT Technician with a strong focus on technical writing to join our growing operations in Ireland. In this role at CAI, the Quality Control IT Technician will:
- Support Quality Control by ensuring compliance with data integrity (DI) and IT standards throughout all documentation and equipment qualification activities.
- Assist in the preparation, review, and management of technical documents related to IT systems and data integration, focusing on accuracy, clarity, and adherence to regulatory standards.
- Develop and maintain clear procedures for data handling, system validation, and IT processes to ensure robust quality and DI practices are embedded within workflows.
- Review and verify Test Outlines and Procedures (TOPs) for IT systems, ensuring alignment with quality and DI specifications.
- Help coordinate IT system qualification activities, including data verification and validation tasks, while adhering to timelines and quality benchmarks.
- Prepare and maintain Qualification Summary Reports (QSRs) and other documentation to track compliance with quality and DI standards.
- Conduct reviews of system Design Evaluations, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to verify quality outcomes for IT systems.
- Manage QC processes related to IT qualifications, including document control, change controls, and oversight of DI compliance.
- Collaborate with IT project teams, contractors, and vendors to execute and validate testing, ensuring strict adherence to data integrity and quality control.
- Allocate resources and support the organization of documentation and materials needed to meet QC and IT deliverables.
- Provide quality assurance support throughout IT system qualification, ensuring that all documentation meets regulatory and DI requirements.
Position Requirements:
- BS or MS in a relevant science or engineering field, or equivalent experience.
- 3+ years of industry related experience
- Strong oral and written communication skills, with a focus on clear documentation and reporting.
- Excellent problem-solving skills with a Quality Control mindset.
- Strong customer-service orientation.
- Proficient in life science manufacturing processes such as biotech, aseptic fill/finish, oral solid dose (OSD), and gene therapy, or with equivalent experience.
- Willing and able to travel domestically and internationally, if required.