Job Overview
We are seeking a Quality Assurance Specialist to join our team in the validation and quality assurance of site equipment, utilities and processes in compliance with procedures. This crucial role supports the growth trajectory in delivering essential products to valued customers.
Responsibilities
* Coordinate and actively participate in the validation and quality assurance of site equipment, utilities and processes in compliance with procedures.
* Review validation protocols and final reports, ensuring they meet cGMP standards.
* Manage validation investigations and implement corrective actions as needed.
* 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.
* Have an understanding of the concepts, principles, and techniques of statistics and how to apply these to datasets, identifying patterns and drawing actionable insights.
* Participate in continuous improvement programs to enhance manufacturing, quality, safety, and training systems.
* Review, update and maintain existing quality management processes and procedures.
* Initiate non-conformances/CAPAs and complete investigations as required.
* Perform risk management activities (e.g., FMEA, risk assessments) to ensure the safety and effectiveness of products.
* Be responsible for planning, implementing and managing compliance of manufacturing and production processes with internal and external safety, quality and regulatory standards requirements for worldwide distribution.
* Monitor and report on quality metrics, such as defect rates and process capability.
Requirements
* 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.
* Be proficient Microsoft Office and database applications (e.g. Excel and MiniTab or similar).
* Have critical thinking, solid decision making and problem-solving skills.
* Have strong written and oral communication and presentation skills.
What We Offer
* A front row seat to life-changing technology.
* A full and comprehensive benefits program.
* Growth opportunities on a global scale.
* Access to career development through in-house learning programs and/or qualified tuition reimbursement.
* An exciting and innovative industry-leading organization committed to its employees, customers, and the communities it serves.