Facebook pixel

Senior Quality Specialist
Confirmed live in the last 24 hours
San Bruno, CA, USA
Experience Level
Desired Skills
  • Bachelor's degree required. Bachelor's degree in a scientific discipline, preferred
  • 5+ years of experience in Quality, Document Control
  • Working knowledge of 21 CFR 820 and ISO 13485 requirements
  • Arena PLM experience is strongly preferred for this position
  • Strong written and verbal communication skills and process
  • Self-motivated and passionate about advancing the field of cell therapies
  • Self-awareness, integrity, authenticity, and a growth mindset
  • Establish, execute, and maintain a PLM Quality System including creation of operating procedures (Standard Operating Procedures and Work Instructions), day to day maintenance, and document control support of the DHF
  • Provide leadership and independently perform document control activities, including, but not limited to: Document Change Order (DCO), Engineering Change Order (ECO), and Engineering Change Request (ECR) packages including review for accuracy and completeness
  • Updating Standard Operating Procedures (SOP), Work Instructions (WI), and Engineering drawings for parts and other relevant documents
  • Create and revise templates for engineering use in the document control system
  • Independently facilitates the DCO/ECO process including formatting, coordinating the review and approval process, tracking and routing controlled documents, and releasing documents into the PLM system in a timely manner
  • Provide user assistance and training on document control and record management systems, processes, and procedures
  • Provide support for new and/or existing PLM users
  • Coordinate/administrate PLM and documentation systems training
  • Support new product introduction, production batch records change control and BOM setup in the PLM system
  • Review of documents for completeness, adherence to company guidelines for formatting, and review of authorization for approvals
  • Monitor status of in-process document changes to ensure timely completion
  • Maintain master documents and records as required by applicable regulations such that required documentation is retrievable and files are accurate, complete and well organized
  • Drive improvement and effective use of Cellares' Electronic Document Management System
  • Assist with maintaining systems to ensure integrity and security of all documents containing data relevant to product quality and/or quality systems
  • Assist in quality audits including document preparation and record retrieval
  • Create and maintain monthly quality metric reports

51-200 employees

Cell therapy solutions