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Senior Quality Control Specialist (Raw Materials)

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 Quality Control Manager, the QC Specialist will serve as the raw material subject matter expert and be responsible for the establishment of the Vedanta Raw Material program, including qualification, inspection, and sampling of raw materials used in the manufacturing of GMP products. The QC Specialist will be responsible for establishing and maintaining phase-appropriate raw material specifications, testing requirements, and process documentation.

Here's What You'll Do:
  • Establish Vedanta’s raw material program and material qualification plan by authoring procedures and performing tasks in accordance with FDA and EMA requirements
  • Represent Vedanta Quality Control as subject matter expert of the raw material program
  • Manage raw material timelines and activities performed at Vedanta’s contract testing facilities 
  • Perform inspection, sampling, and release of incoming raw materials to support Vedanta’s internal manufacturing activities
  • Draft and revise raw material specifications 
  • Participate in non-conformance investigations, supplier change notification assessments, corrective and preventative actions, and change controls with specific emphasis on utilization of product and compliance knowledge 
  • Participate in projects for continuous improvement initiatives within QC department
  • Assist in preparation and review of quality records including standard operation procedures (SOPs)

Requirements:
  • BSc. in a life science with 5+ years in a GMP Quality Control environment
  • Experience in establishment of raw material qualification programs
  • Strong knowledge of USP, EU, ISO compliance
  • Excellent written and oral communication skills
  • Experience working in a higher compliance environment is an asset
  • Experience managing relationships with CTOs and vendors
  • 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
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