Sr. Document Control Specialist

About us

Headquartered in Menlo Park, Ionpath Inc. delivers high-definition spatial proteomics, revolutionizing tissue imaging and analysis to accelerate discovery and improve human health. Ionpath's MIBI™ (multiplexed ion beam imaging) Platform breaks through the limitations of traditional IHC, enabling deep understanding of the tissue microenvironment with highly multiplexed quantitative single-cell analysis. With MIBI technology and the expertise of world class pathology and data science teams, Ionpath provides actionable insights to translational and clinical researchers at leading pharma, biotech, and research organizations in immuno-oncology, immunology, neuroscience and infectious disease research.

About the role

Responsible for general support and maintenance of the Quality System within the requirements of 21CFR820, ISO 13485:2016 and EU IVDR 2017/746 for In Vitro Diagnostics, including Document Control, Calibration/PM, BOM/Parts change management, Operation Quality supports.

About You

Responsibilities

• Performs day to day Document Control activities, processing and releasing documentation, supporting ongoing projects and activities; maintaining records while ensuring document accuracy, quality and data integrity.
• Trains and provides support to end users on the electronic Document Management System (Arena PLM) requirements and workflows.
• Maintain document records and change control processes in accordance with IONpath's policies and procedures.
• Schedule, conduct and facilitate periodic document review to ensure documents remain current and compliant to internal requirements
• Supports employee on-boarding with Quality-related tasks.
• Supports maintenance of training matrix and requirements.
• Provide support to department managers in establishing employee's training requirements.
• Supports audits (External/Internal).
• Responsible for the internal Calibration/Preventive Maintenance Program.
• Reports quality metrics for the purpose of driving continuous improvement of the Quality System.
• Other quality related duties as required.

Requirements

• Must be detailed oriented
• Minimum of 5 years in Document Control in a regulated environment.
• Direct experience maintaining procedures in a FDA regulated environment.
• Experience with Electronic Document Management System and experience with Arena PLM is a plus.
• Experience in a regulated GMP environment and familiarity with the associated terminology and workflow.
• Proficiency in general computer skills, and with Microsoft Word, Excel, PowerPoint, Google Suite.
• Ability to read and interpret technical procedures, SOPs, regulation and standards.
• Strong written and verbal communication skills.
• Team driven results mindset and ability to work independently.
• Ability to prioritize and manage multiple projects.

Education: Bachelor's degree or equivalent and a minimum of 5 years related experience is required.

Ionpath is an equal opportunity employer that offers an exciting and collaborative scientific environment, in addition to a competitive compensation package that includes salary, stock options, 401(k) and a comprehensive benefits package.

For more information or to apply, please apply here or see www.ionpath.com/careers