Job Overview
As a Quality Control Engineer, you will play a crucial role in ensuring the quality of equipment and processes in our facility. This is an exciting opportunity to join a dynamic team and contribute to the success of our organization.
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Key Responsibilities
* Support Quality Control compliance throughout all equipment qualification activities, ensuring safety and regulatory standards are met.
* Assist in the documentation and execution of equipment qualification processes, from initial assessments through to Operational Qualification (OQ), with an emphasis on accuracy and quality.
* Follow established procedures and protocols for new equipment qualification to embed quality practices within workflows.
* Review and complete Test Outlines and Procedures (TOPs) to verify alignment with quality specifications.
* Help plan and organize commissioning materials and consumables, ensuring they meet quality requirements.
* Monitor equipment qualification activities to ensure timelines are met without compromising quality standards.
* Prepare and maintain Qualification Summary Reports (QSRs) and related documentation to confirm adherence to quality standards.
* Participate in equipment Design Evaluations, Factory Acceptance Testing (FAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), maintaining a focus on quality outcomes.
* Manage quality control processes related to equipment qualifications, including documentation control, change controls, and punch list tracking.
* Work closely with project contractors and equipment vendors to perform and verify tests, ensuring strict quality control is maintained.
* Support quality assurance tasks throughout the equipment qualification process to ensure consistent quality standards are upheld.
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Requirements
* Bachelor's or Master's degree 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.