| The Quality Assurance Specialist will perform and administer Quality Assurance (QA) activities at BioLegend in accordance with Biolegend’s Vision, Mission, Quality Policy, and Quality Objectives for implementation, maintenance and improvement of BioLegend's Quality Management System (QMS). This position will be an integral part of the Quality Assurance team and will be responsible for QMS documentation, working closely with other departments to provide training regarding best practices, supporting new product validations, and supporting the QMS training program as a whole. Essential Functions Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. - Create, review, and approve QMS documentation for the company and be responsible for document management and filing
- Assure products (current and new), materials and processes, including their applicable documentation, are complaint with applicable QMS requirements
- Work with internal department heads to ensure implementation of uniform quality practices, share/train best practices, and work with management to ensure that the principles of quality and compliance are included in the company's culture
- Support change control, Engineering control, new product and validations (equipment, methods, and processes), and risk management
- Support the QMS training program, including ISO13485 and regulatory requirements, and act as a resource to ensure quality compliance
- Support non-conforming activities, corrective and preventive actions, root cause analyses, and process improvements
- Complete resolutions towards customer requests, customer feedback, inspections, audits, deviations and other related issues
- Conduct internal audits and investigations
- Support, host, and lead, customer, supplier, and regulatory audits, including timely document search and delivery during audits, as necessary
- Support supplier performance and evaluation
- Support Management Review with metrics data on Quality processes
- Create reports for QA, including detailed analyses
- Other duties as required
Competencies - Accountability
- Dependability
- Quality of work
- Teamwork
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