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Document Control Specialist

Cambridge, MA · Biotech/Pharmaceutical

About Vizgen:
Vizgen is a rapidly growing company commercializing the next generation of spatially resolved genomic profiling tools that enable researchers to gain new insight into the biological systems that underlie human health and disease. The company's groundbreaking MERSCOPE product utilizes MERFISH spatial transcriptomics technology to image RNA molecules with high accuracy and unrivaled detection efficiency at subcellular resolution. MERFISH provides transformative insight into a wide range of tissue-scale basic research and translational medicine in oncology, immunology, neuroscience, infectious disease, developmental biology, and regenerative medicine. For more information, go to www.vizgen.com
 

Summary:
Working closely with Vizgen’s R&D and Operations teams, the Document Control Specialist will assist project teams with preparing, maintaining, and managing documents and workflow processes as well as working to continuously improve the company’s quality system.  

Key Responsibilities:

  • Administer the company change order processes

  • Implement a documentation control system that dovetails with Vizgen MRP systems

  • Work with project teams across different functional groups to draft documentation and support the quality management system

  • Support the continuous improvement of the document control, product lifecycle management, and quality management systems.

  • Create reports on various systems being administered as needed

  • Assist with the creation of templates as needed

  • Support the product development process and maintaining the organization and accessibility of documents used throughout the process

  • Train Vizgen employees on the document control processes


Requirements and Qualifications:

  • BS/BA degree with 3+ years of document control experience in the biotech instrument industry

  • Knowledge of QA processes and ISO regulatory requirements is preferred

  • Previous experience in the use of PLM preferably with Arena PLM

  • Proficiency with computers and Microsoft products

  • Ability to handle multiple tasks and detail oriented

  • Ability to work in a fast-paced dynamic environment

  • Excellent cross functional team communication and participation is essential

  

WE ARE AN EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER
Vizgen affords equal employment opportunity to all qualified persons regardless of race, color, religious creed, national origin, age, military status, sexual orientation, disability, genetic information, gender identity, gender expression or gender unless based upon a bona fide occupational qualification.

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