Vector Laboratories, a Maravai LifeSciences company, is seeking a Quality Assurance Specialist to join our growing team. This Quality Assurance Specialist will be working as part of the Quality Assurance team. You will use your training and skills towards the implementation, maintenance, and continuous improvement of the Quality Management System. You will be ensuring compliance with applicable domestic and international standards and regulations. The qualified individual will be responsible for managing quality events such as OOS, nonconformances, CAPAs, escalated complaints, perform product releases, and support other quality system processes. This is a highly visible, hands-on position that must be able to work independently and as part of a team.
Vector Laboratories, located in Burlingame, CA, offers competitive wages and a full benefits package including medical, dental, vision, LTD, and a retirement plan.
- Manage OOS, nonconformance, CAPA, and escalated complaint systems.
- Review and approve Phase II OOS
- Review and approve batch records for product release
- Provide training in ISO requirements and quality procedures
- Assist in internal and external audits, including customer audits
- Assist with document and record control functions as needed
- Report and analyze monthly quality system metrics from excel logs and electronic Quality Management System
- Lead quality improvement projects, including planning, communicating, developing action plans while providing regular project updates
- Assure compliance with all in-house or external specifications to standards
- Identify quality issues/discrepancies and effectively resolve discrepancies within the organization
- Other duties as assigned
- Work with investigation owners to assess root cause, corrections, corrective actions, preventative actions, and effectiveness
- Quality professional with a minimum of 3 years in a quality role in a life science industry
- Requires knowledge of ISO 9001, ISO 13485, 21 CFR 820, or 21 CFR 211
- Proficient in Microsoft Office; experience with NetSuite ERP & MasterControl a plus
- Strong verbal and written communication skills
- Strong organizational and problem solving skills
BS Degree in a scientific discipline