Vector Laboratories is seeking a Quality Assurance Specialist responsible for implementation, maintenance, and continuous improvement of the Quality Management System, including CAPA, non-conformances, deviations, product approval, design control, and supplier management, etc. This role will ensure compliance with applicable domestic and international standards and regulations. Responsibilities include:
- Ensuring organizational conformation with applicable HR related regulations and statutes as well as organizational procedures and policies.
- Manage the nonconformance, deviation, complaint, and CAPA systems. Work with investigation owners to assess root cause, corrections, corrective actions, preventative actions and effectiveness.
- Provide training in ISO requirements and quality procedures.
- Review and approve batch records for product release.
- Assist in internal and external audits, including customer audits.
- Work with R&D and custom product management for design control implementation for new and custom products, including defining user needs, risk management, verification and validation, design review requirements, etc.
- Assist in supplier quality management, including supplier qualification, quality agreements, maintain approved vendor list (AVL), etc.
- Assist with document and record control functions as needed.
- Report monthly quality system metrics.
- Lead quality improvement projects, including planning, communicating, developing action plans, and providing regular project updates.
- Assure compliance with all in-house or external specifications to standards.
- BS Degree in scientific discipline.
- 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.
- Strong verbal and written communication skills.
- Strong interpersonal skills.
- Strong problem solving skills.
- Self motivated and able to organize and prioritize mulitple tasks.
- Indentify quality issues/discrepancies and effectively resolve discrepancies within the organization.
Vector Laboratories is a rapidly growing biotech firm in Burlingame, CA that offers competitive wages and a full benefit package including medical, dental, vision, LTD, and a retirement plan.