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Contract – Document Control & Training Specialist

Cambridge, MA
About Vedanta Biosciences, Inc.
 
Vedanta is pioneering the development of a new class of therapies based on defined bacterial consortia that act by modulating the human microbiome. Modulation of the human microbiota holds enormous promise to treat a broad range of immune and infectious diseases in ways that are completely different to existing drug classes. Breakthrough discoveries of our scientific team in the field of mucosal immunology have led to the first rationally designed drug candidates in the microbiome field.

We believe that in the near future, doctors will have an entirely new option to treat patients: bacterial consortia therapeutics. We are enabling this new drug class with groundbreaking and industry-leading scientific work powered by large-scale capabilities to identify, screen, and manufacture bacteria with drug-like properties. Our team is at the core of all we do - and we're excited to meet new team members!  
 
About Us, About You
 

At Vedanta, we value diversity in all its forms and are looking for candidates with a wide variety of perspectives, backgrounds, education, and experiences. We believe that a diverse and inclusive workforce builds the strongest team possible.

We're proud of our workplace culture. Our Vedanta Values inspire us to be the best professionals and colleagues possible. Our values are:
Respect - Collaboration - Execution - Effective Communication - Problem Solving - Scientific Thoroughness

The Role:

The Document Control & Training Specialist is responsible for the performance of a wide variety of activities to ensure compliance with applicable regulatory and CGMP requirements.  This position will provide QA operational support for all Vedanta Biosciences CGMP facilities.  This position will serve as a key QA contact for Vedanta’s Document Control and Training Programs.
 
Here’s What You’ll Do:
  • Perform Document Control and Training operations within Veeva Vault QualityDocs.
  • Manage Document Change Controls.
  • Maintain the Training Matrix for CGMP employees and contractors.
  • Coordinate and assist with batch record and logbook generation and archival for CGMP operations.
  • Ensure CGMP documentation is archived in accordance with applicable procedures.
  • Support the off-site archival of CGMP documentation at Iron Mountain.
  • Support continuous improvement efforts surrounding the Document Control & Training Programs.
  • Assist with the day-to-day quality operations, as applicable.
 
Requirements:
  • Bachelor’s degree with a minimum of 2 years of related work experience and demonstrated knowledge of scientific principles
  • Experience with document control and training functions
  • Demonstrated ability to interface cross-functionally in a collaborative manner
  • Travel between both Acton and Cambridge facilities is required
  • Ability to work in a fast-paced setting and adjust to a changing environment
  • Must be able to function with minimal direct supervision
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