Job Description
The Quality System Specialist will play a key role on the company’s Quality Assurance team, driving and administering quality system activities in multiple areas of focus. This position will ensure effective management of key 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. The Quality System Specialist 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.
• Conduct batch history records (BHR) reviews that include but are not limited to; completeness, accuracy, the use of good documentation practices, etc. prior to approval and product release.
• May support the Complaint Change Review Board through assisting in complaint investigations and developing corrective actions to address complaints.
• Promote a collaborative approach with team members, functional departments, and other LGC sites.
• Monitor and report on designated quality/business metrics and creation of new 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 in developing effective Quality documents (Batch History Records and related technical SOP’s), ensuring 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.
Qualifications
_ Qualifications:_
Additional Information
What we offer (US based-employees):