Contract - Document Control & Training Specialist

Title:                   Contract - Document Control & Training Specialist

Location:           Cambridge, MA

Reports to:       Director, Quality Assurance Compliance      

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:

• Performs Document Control and Training operations within Veeva Vault QualityDocs.
• Manages Document Change Controls.
• Maintains the Training Matrix for CGMP employees and contractors.
• Coordinates and assists with batch record and logbook generation, issue and archival for CGMP operations.
• Ensures CGMP documentation is archived in accordance with applicable procedures.
• Supports the off-site archival of CGMP documentation at Iron Mountain.
• Supports continuous improvement efforts surrounding the Document Control & Training Programs.
• Assists with the day-to-day quality operations of product change overs, as applicable.

Requirements:

• Bachelor’s degree with a minimum of 2 years of related work experience and demonstrated knowledge of scientific principles
• Has 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

Why join Vedanta Biosciences:

Vedanta is pioneering the development of a new class of therapies 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. Vedanta was founded by PureTech Health and a team of world-renowned experts in immunology and microbiology. 

We invite you to explore our site to learn more about our company and how our discovery platform enables identification of bacterial consortia with drug-like properties and their manufacture to GMP standards.

Vedanta is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vedanta will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Vedanta Biosciences requires all employees to be fully vaccinated against COVID-19 and newly hired employees must be fully vaccinated prior to their employment start date. Vedanta Biosciences will consider accommodations for individuals who are unable to be vaccinated against COVID-19 due to a qualifying medical condition or disability or a sincerely held religious objection.