About the Role
We are seeking a skilled QA Engineer to join our team in the validation and quality assurance of site equipment, utilities and processes. This role plays an integral part in ensuring compliance with our procedures and supporting the growth trajectory of our organization.
Responsibilities
As a QA Engineer, you will coordinate and actively participate in the validation and quality assurance of site equipment, utilities and processes in compliance with our procedures. You will review validation protocols and final reports, ensuring they meet cGMP standards. Additionally, you will manage validation investigations and implement corrective actions as needed.
You Will:
* Coordinate and participate in the validation and quality assurance of site equipment, utilities and processes.
* Review validation protocols and final reports to ensure compliance with cGMP standards.
* Manage validation investigations and implement corrective actions.
* Communicate regularly with peers and management regarding activities, escalating issues or concerns as necessary.
* Design methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products.
* Participate in continuous improvement programs to enhance manufacturing, quality, safety, and training systems.
* Initiate non-conformances/CAPAs and complete investigations as required.
Requirements
To be successful in this role, you will have QA experience in process and equipment validation, with hands-on experience in end-to-end process validation. Experience in automation validation is highly desirable. Additionally, you will be proficient in Microsoft Office and database applications (e.g., Excel and MiniTab or similar). Strong critical thinking, decision-making, and problem-solving skills are also essential.
Benefits
In this role, you will have access to career development through in-house learning programs and/or qualified tuition reimbursement. You will also be part of a dynamic and innovative organization committed to employee well-being, customer satisfaction, and community involvement. A comprehensive benefits package and opportunities for growth on a global scale are also available.