">
Junior Quality Control Specialist
">">
About Equipment Validation
">[Job Overview]">
We are looking for a detail-oriented professional to join our operations in Ireland. As a Junior Quality Control Specialist, you will play a key role in ensuring the quality and compliance of our equipment qualification activities.
">
Main Responsibilities:
">
">
* Support and assist with Quality Control compliance for equipment qualification activities, ensuring adherence to safety and regulatory standards.
">
* Help document and execute equipment qualification processes, from initial assessments to Operational Qualification (OQ), focusing on accuracy and attention to detail.
">
* Follow established procedures and protocols for new equipment qualification to help embed quality practices within workflows.
">
* Assist with the review and completion of Test Outlines and Procedures (TOPs), verifying alignment with quality specifications.
">
* Support the planning and organization of commissioning materials and consumables, ensuring they meet required quality standards.
">
* Monitor equipment qualification activities to ensure that timelines are met while maintaining high quality standards.
">
* Assist in preparing and maintaining Qualification Summary Reports (QSRs) and related documentation to ensure compliance with quality standards.
">
* Participate in equipment Design Evaluations, Factory Acceptance Testing (FAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), with a focus on achieving quality outcomes.
">
* Assist in managing quality control processes related to equipment qualifications, including documentation control, change controls, and punch list tracking.
">
* Collaborate with project contractors and equipment vendors to perform and verify tests, ensuring quality control is upheld.
">
">
Requirements:
">
">
* Bachelor's or Master's degree in a relevant science or engineering field, or equivalent experience.
">
* Minimum 2 years of industry-related experience in a similar role.
">
* Strong oral and written communication skills, with a focus on clear documentation and reporting.
">
* Strong problem-solving skills with a focus on Quality Control.
">
* Customer-service oriented and able to collaborate well with internal teams and external vendors.
">
* Familiarity with life science manufacturing processes such as biotech, aseptic fill/finish, oral solid dose (OSD), and gene therapy, or equivalent experience.
">
* Willing and able to travel domestically and internationally, if required.
">
">
This is an excellent opportunity to work with a dynamic team and contribute to the success of our organization.
">
We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.
">
If you are a motivated and detail-oriented individual with a passion for quality control, we encourage you to apply for this exciting opportunity.
">