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Contract - Quality Control 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 position directly supports Vedanta’s in-house GMP manufacturing capabilities including programs in multiple phases of development. 
 
Previous experience with aseptic technique, environmental monitoring, personnel monitoring, general USP microbiological and chemistry testing/data review preferred.  The individual will also work closely with other departments such as Manufacturing, Supply Chain, QA, and external vendors to ensure timely testing and release of Vedanta products. Occasional travel to Vedanta’s Acton, MA manufacturing facility may also be required.

Here’s What You’ll Do:
  • Review contract test lab data, protocols, reports, and quality events (deviations, OOS etc.)
  • Author and revise SOPs, protocols, and reports
  • Participate in continuous improvement projects to support the growth of the company
  • Perform routine EM/PM in support of GMP manufacturing of Vedanta in-house products
  • Participate within the QC team to meet group and company goals
Requirements:
  • BS in a Scientific Discipline
  • Minimum 5+ years working in a GMP Quality Control test lab
  • Experience working within QMS systems, ownership of deviation investigations, OOS, CAPAs and Change Controls
  • Experience with QC continuous improvement projects; project management skills a plus
  • Must be able to gown and enter manufacturing environments
  • Must be able to work with disinfectants such as Spor-Klenz, Vesphene, and IPA
  • Direct experience with aseptic sampling and testing techniques
  • Strong laboratory and organizational skills, attention to detail, flexibility, and the ability to work within a team environment
  • Proficient in Outlook, MS Word, Excel, and lab-based data management systems
  • Knowledge of USP, EU, ISO compliance
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