Job Summary
About This Role
We are seeking a highly skilled Quality Control (QC) professional to join our team. As a QC Technician, you will play a critical role in ensuring the quality and integrity of our systems.
Responsibilities
1. Support Quality Assurance by ensuring compliance with data integrity standards throughout all documentation and equipment qualification activities.
2. Assist in preparing, reviewing, and managing technical documents related to IT systems and data integration, focusing on accuracy and regulatory adherence.
3. Develop clear procedures for data handling, system validation, and IT processes to ensure robust quality practices are embedded within workflows.
4. Review and verify Test Outlines and Procedures for IT systems, ensuring alignment with quality specifications.
5. Coordinate IT system qualification activities, including data verification and validation tasks, while adhering to timelines and quality benchmarks.
6. Prepare Qualification Summary Reports and other documentation to track compliance with quality standards.
7. Conduct reviews of system Design Evaluations, Installation Qualification, Operational Qualification, and Performance Qualification to verify quality outcomes for IT systems.
8. Manage QC processes related to IT qualifications, including document control, change controls, and oversight of DI compliance.
9. Collaborate with IT project teams, contractors, and vendors to execute and validate testing, ensuring strict adherence to data integrity and quality control.
10. Allocate resources and support the organization of documentation and materials needed to meet QC deliverables.
To be successful in this role, you will need:
* Bachelor's or Master's degree in a relevant science or engineering field, or equivalent experience.
* At least 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.
* Proficiency in life science manufacturing processes such as biotech, aseptic fill/finish, oral solid dose, and gene therapy, or equivalent experience.
* Willingness and ability to travel domestically and internationally, if required.