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Quality / Senior Quality Compliance 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:

Reporting to the Senior Manager of Quality Operations, this professional is responsible for the performance of a wide variety of activities to ensure compliance with applicable regulatory and CGMP requirements by conducting data and document reviews and analysis.  Provide QA support for Cambridge and Acton operations. Serve as key QA contact for for Quality Management System activities (CAPA, Change Control, Deviations).  Lead or support internal and supplier quality audits.
 
Here’s What You’ll Do:
  • Coordinates and assists with batch record and logbook issuance, review and data auditing for quality assurance, manufacturing support.
  • Assists with tracking the disposition of products manufactured by Vedanta.
  • Responsible for the disposition labeling of Drug Substance and Bulk Drug Product.
  • Supports Quality activities at the Acton and Cambridge facilities.
  • Interfaces with Manufacturing, Technical Operations, Supply Chain, Facilities and Quality Control to assist with QA activities.
  • Coordinates, prepares and approves the process documentation for New Product Introductions, Product Change Over, as well as the manufacturing of Vedanta products; coordinates with Manufacturing to conduct QA product changeover / walkthroughs of GMP areas, cleanrooms and room release activities.
  • Collaborates with other departments for investigations, risk assessments, EM alerts, change controls, deviations, and CAPA.
  • Review and approval of Validation SOPs and documentation.
  • Ensures Corrective Actions are implemented and assists in investigation of root cause.
  • Creates and revises QA procedures.
  • Lead Internal audits.
  • Lead or support supplier quality activities, including supplier assessments, evaluations, audits, supplier change notifications and supplier corrective actions.
Requirements:
  • Requires a bachelor's degree with minimum of 3 years of related work experience and demonstrated knowledge of scientific principles.
  • Has experience with batch record review and lot release functions and the ability to interface cross-functionally in a collaborative manner. Quality Systems review experience required.
  • Has experience conducting investigations and risk assessments.
  • Has experience performing Quality audits (internal and /or external).
  • Travel between both Acton and Cambridge facility will be required.
  • 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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