게시된 위치: 기타 속 이다호 | Posted: |
Job Description
The Quality Assurance Associate will play a key role on the company’s Quality Assurance (QA) team, ensuring the Quality Management System (QMS) conforms to the relevant ISO quality standard and effectively meets applicable regulatory, customer and LGC business requirements. Quality Assurance Associate will have responsibility for supporting the documentation, effective maintenance, and improvement of the site’s Quality Management System to maintain regulatory compliance and ISO certifications.
Effectively execute on operational duties specific to quality training, change management and document control, record review and retention, customer feedback and complaint management, and monitoring and measurement of quality and business objectives
Conduct batch history records (BHR) reviews for completeness, accuracy, and use of good documentation practices prior to approval and product release
Administer the document control process and quality records; serve as subject-matter expert in this area
Serve as the coordinator of the company’s quality training, site supplier management program
Assist, as directed, in complaint investigations and developing corrective actions to address complaints
Monitor and report on designated quality/business metrics
Assist with reporting to top management on the performance and integrity of the QMS and needs for improvement
Promote awareness of quality and customer requirements throughout the organization
Partner with Operations to ensure effective administration of QA documentation (Batch History Records and related technical SOP’s) and adherence to product labelling requirements
Coordinate with QA team members on the maintenance, execution and improvement of related QMS processes: nonconformances, corrective and preventive action, process/product deviations, training management and complaint management
Support development, maintenance, improvement, and implementation of customer facing documentation (Certificates of Analysis, User Manuals, Application Notes, Customer Quality Questionnaires) as necessary.
Participate in internal and external audits as needed
Promote a positive quality culture welcoming open communication and feedback
Understand and comply with ethical, legal, and regulatory requirements applicable to the business