Quality Assurance Specialist

Organization
Vector Laboratories
Job Location
30 Ingold Road
Burlingame, CA 94010
Job Description

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.


Qualifications

  • 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. 

How to Apply

Please email resume to jobs@vectorlabs.com

About Our Organization

Vector Laboratories is a worldwide leader in the development and commercialization of labeling and detection reagents for immunohistochemistry, immunofluorescence, DNA/RNA detection & glycobiology.  We have developed a number of key technologies that revolutionized the field of IHC including VECTASTAIN® ABC systems, ImmPRESS™ Micropolymer Reagents, Mouse on Mouse (M.O.M.) Immunodetection Systems, and VECTASHIELD® Antifade Mounting Media for fluorescence applications. We are fully committed to developing new research tools to help scientists reach new visualization frontiers.   Over the past 40 years, our products have enabled progress in biomedical research and medicine and have been cited in over 300,000 publications worldwide.

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