Supervisor, Document Control

Company Description

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 visitand follow the company onLinkedInX (Twitter)andFacebook.

Essential Duties and 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 companys 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 Healths 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

Qualifications

• 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
• Certification in Continuous Improvement methodologies (e.g. Lean Six Sigma or equivalent) preferred
• Strong understanding of FDA 21 CFR Part 820 ISOCFR 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

Work Environment:

Employee may be required to lift routine office supplies and use office equipment. Majority of the work is performed in a desk/office environment; however there may be exposure to high noise levels fumes and biohazard material in the laboratory environment. Ability to sit for extended periods of time.

Hybrid Work Model: This section is applicable to onsite employees who are eligible for hybrid work location as specified by management and related policies. Guardant has defined days for in-person/onsite collaboration and work-from-home days for individual-focused time. All U.S. employees who live within 50 miles of a Guardant facility will be required to be onsite on Mondays Tuesdays and Thursdays. We have found aligning our scheduled in-office days allows our teams to do the best work and creates the focused thinking time our innovative work requires. At Guardant our work model has created flexibility for better work-life balance while keeping teams connected to advance our science for our patients.