Facebook pixel

Senior Manager
Document Control-ECO, P-2162
Updated on 1/26/2023
Locations
Pleasanton, CA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Requirements
  • 7+ Years as a Document Control Manager or equivalent
  • Hands-on experience in ISO and quality management systems implementation and certification
  • Hands-on experience with Arena PLM system selection and implementation
  • Strong written and verbal communication skills and process
  • Experienced with internal, external auditing programs with great attention to detail
  • Self-Starting, detail oriented, quick learner, strategic, creative, and analytical
  • Degree in Sciences
  • 5+ Years working in Life Sciences or Bio-Pharmaceutical industries
  • Arena PLM/ERP integration experience
Responsibilities
  • Lead and manage the document control team that processes document changes (ECO), engineering change requests (ECR) and record retention policies
  • Develop and maintain the administration and approval matrix of all engineering changes; support QA in managing the QMS flow for Deviations, NCR, CAPA, etc
  • Manage documentation archive of product design history files, validation plans and reports, and production records. Ensure all document control processes and retention of records are in compliance with applicable ISO and QMS standards
  • Collaborate with Quality Assurance team to create training contents for document related quality management processes
  • Oversee part number creation and revision change of items. Work with Productivity Engineering team in the maintenance of item templates to ensure item functionality in the ERP system
  • Lead projects associated with global process harmonization to ensure consistent document control practice at different sites
  • Create department KPIs and monitor team performance
  • Ensure proper document and record management resourcing are established to support the growth of the company
  • Perform other quality related duties as assigned
10x Genomics

201-500 employees

DNA sequencing insight platform
Company Overview
10x Genomics is on a mission to develop innovative instruments, reagents, and software that allow you to see your biological system at a resolution that matches its complexity. The company enables scientists to advance their research, allowing them to address scientific questions they did not even know they could ask.
Benefits
  • Comprehensive health benefits
  • Generous time off
  • Parental leave
Company Core Values
  • We are mission driven and stay relentlessly focused on that mission.
  • We operate from first principles.
  • We strive for exponential impact.
  • We put WE before ME.
  • We believe exceptional talent delivers outsized results.