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Senior Quality Assurance 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

About the role

Reporting to the Associate Director of QA, the Senior Quality Assurance Specialist is responsible for performing a wide variety of activities to ensure compliance with applicable regulatory and CGMP requirements by conducting data and document reviews and analyses.  The individual will provide QA support for Cambridge and Acton operations and will lead batch record reviews and disposition activities. Additionally, this person will serve as the key QA contact for Quality Management System activities (CAPA, Change Control, Deviations), and will lead or support internal and supplier quality audits.
 
Here’s What You’ll Do:
  • Coordinate and assist with batch record and logbook issuance, review, and data auditing for quality assurance and manufacturing support.
  • Lead the disposition of products manufactured by Vedanta.
  • Support Quality activities at the Acton and Cambridge facilities.
  • Interface with Manufacturing, Technical Operations, Supply Chain, Facilities, and Quality Control to assist with QA activities.
  • Coordinate, prepare, and approve the process documentation for New Product Introductions, Product Change Over, as well as the manufacturing of Vedanta products; coordinate with Manufacturing to conduct QA product changeover / walkthroughs of GMP areas, cleanrooms, and room release activities.
  • Collaborate with other departments for investigations, risk assessments, EM alerts, change controls, deviations, and CAPAs.
  • Review and approve Validation SOPs and documentation.
  • Ensure Corrective Actions are implemented and assist in investigation of root cause.
  • Support the administration of computerized systems (e.g., Veeva Vault)
  • Create and revise QA procedures.
  • Support Internal audits.
  • Lead or support supplier quality activities, including supplier assessments, evaluations, audits, supplier change notifications, and supplier corrective actions.
Requirements:
  • Bachelor's degree with minimum of 5 years of related work experience and demonstrated knowledge of scientific principles.
  • Experience with batch record review and product release functions, and the ability to interface cross-functionally in a collaborative manner. Quality Systems review experience required.
  • Experience conducting investigations and risk assessments.
  • Experience performing Quality audits (internal and /or external).
  • Travel between both Acton and Cambridge facilities will be required.
  • Veeva Vault experience a plus.
  • Ability to work in a fast-paced setting and adjust to changing environment. Must be able to function independently with minimal direct supervision.
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