Supervisor, Document Control

Guardant Health•Redwood City, CA

36d•Hybrid

About The Position

Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.

Requirements

B.S. degree in a scientific discipline or equivalent
5-8 years of document control experience in a medical device or regulated environment including 3+ years in a supervisory role
Strong understanding of FDA 21 CFR Part 820, ISO 13485, 21 CFR Part 11, and document control best practices in a regulated Molecular laboratory
Experience with electronic document management systems (e.g. MasterControl, Veeva, Propel, or equivalent)
Experience with physical records management, archival, and offsite storage programs
Experience validating eQMS software systems and implementing electronic workflows
Excellent leadership, organization, communication, and problem solving skills
Ability to work effectively in a team environment and build strong working relationships
Ability to successfully balance and prioritize multiple ongoing projects/tasks in a fast-paced, deadline driven environment
Ability to identify, analyze and solve problems with minimal direction and escalate concerns to management
Proven attention to detail and accuracy
High degree of initiative and self-motivation
Experience with Microsoft Office suite and Internet for business use

Nice To Haves

Certification in Continuous Improvement methodologies (e.g. Lean, Six Sigma, or equivalent) preferred

Responsibilities

Lead and supervise the Document Control Team to assign tasks, provide training/guidance, monitor performance and workload.
Provide coaching, development, training, and guidance to ensure compliance with document control and records management procedures.
Develop, implement, maintain and continuously improve document control procedures, workflows, and training administration within the eQMS.
Ensure controlled documents follow proper review/approval and revision practices, version control, distribution, and accessibility.
Responsible to ensure Biennial Review of controlled document are completed in accordance to FDA QSR, ISO 13485, CAP, CLIA and internal quality policies.
Responsible for the day-to-day operations of document control department for all controlled documents within the eQMS and the document control file room by routing/approving documents, archival/destruction of documents in the file room, and training administration within the eQMS according to company’s procedures.
Ensure all document, records management, and training administration activities comply with FDA QSR, ISO 13485, and internal quality policies.
Coordinate archival and offsite storage of documents according to retention schedules to ensure secure transfer and logging, and retrieval processes.
Maintain a master inventory of all Control of Records in the file room.
Independently identify and troubleshoot high complexity problems for document control and provide solutions.
Develop and maintain SOPs related to document control, record retention, archival, and file room operations.
Track and report document control metrics required for management review, audit readiness, operational tracking, and continuous improvement programs to report to senior management.
Assist in reviewing and approving quality records as assigned including but not limited to: Manufacturing, Quality Control, Equipment, process monitoring, internal audits, and reports to ensure quality, safety and compliance of Guardant Health’s products.
Implement change as needed at the direction of management.
Create, review, and improve standard operating procedures / other QMS documentation as needed
Represent Quality at cross functional meetings to provide guidance and ensure alignment with organizational quality standards, regulatory requirements, and process improvement initiatives
Ensure procedures and processes are in place that lead to the delivery of quality results and continually assess their effectiveness to drive continual improvement
Responsible for leading/supporting the development, implementation, and continual improvement of the Quality processes (e.g. document control, records control, and training)
Ensure integrity of quality processes are maintained when changes are implemented.
Provide training to members of the Document Control, Quality, and across departments on quality processes, compliance requirements, and best practices.
Create and maintain quality metrics required for management review, audit readiness, operational tracking, and continuous improvement programs to report to senior management
Support internal and external audits as necessary to provide requested documentation in a timely manner
Escalate any issues or concerns with regard to deliverables and work capacity to management promptly
Report all concerns of quality and/or safety to the Supervisor or Safety Officer
Execute special projects and duties as assigned by department manager in a timely manner