QC Technician

at  CAI

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.

• 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