Document Control Specialist II

2 days ago

Brisbane, California, United States BioSpace, Inc. Full time
About this opportunity:

Freenome is seeking a Document Control Specialist II to join our growing Quality team. In this role, you will support our quality and regulatory activities with various authorities, including the FDA, CLIA, and CAP, while ensuring compliance with quality systems like GMP, IVDR, and ISO.

You will work closely with cross-functional teams from Engineering, Regulatory Affairs, and Quality to manage the document management system and learning management system. This position focuses on all aspects of Document Control and Training.

We are looking for someone passionate about maintaining excellence in a fast-paced, high-performance environment, with the drive to contribute significantly to the growth of an organization dedicated to transforming cancer detection and treatment.

Key responsibilities:
  • Manage the processing, review, and approval of all revision-controlled documents
  • Work within the electronic Quality Management System (eQMS) and Document control database
  • Organize and plan the implementation of project-level document batches based on a solid foundation and understanding of key QMS components
  • Periodically review documents and records, for completeness and compliance with QSR 21 CFR § 820, ISO 13485 requirements, and Company procedures
  • Assist in the preparation of documents/metrics for Management Review meetings and maintain meeting records
  • Coordinate, manage, and lead programs related to quality improvement
  • Ensure all documents for other QMS processes such as Approved Supplier List (ASL) and records, or external standards are current
  • Support internal and external audits, supplier audits, and other RA/QA meetings, as needed
  • Work with the QA Document Control Manager to manage document training when new documents are approved or existing documents are revised
  • Support the administration of the eQMS, with accounts creation, training, troubleshooting, management, and system improvements as needed
Requirements:
  • 5+ years of experience in Document Control within the medical device, biotech, life sciences, or similar industries
  • Strong understanding of quality systems, including 21 CFR § 820, ISO 13485, and software development. Familiarity with ISO 15189 and GCLP is a plus
  • Proven ability to build collaborative working relationships; team-oriented yet able to work independently
  • Ability to quickly adapt to changing priorities, manage workloads effectively, and deliver tangible results
  • Excellent interpersonal and communication skills, both written and oral, to effectively interact with all levels of the organization
  • Highly proficient in using a variety of computer applications, with strong skills in Microsoft Word, Excel, and Google Workspace (gSuite) tools
What we offer:
  • US target range of our base salary rate for new hires is $81,175 - $123,500
  • Pre-IPO equity, cash bonuses, and a full range of medical, financial, and other benefits depending on the position offered

Freenome is proud to be an equal-opportunity employer, and we value diversity. Freenome does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

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