Contract - Quality Control Specialist I

Title:                   Contract - Quality Control Specialist I

Location:           Cambridge, MA

Reports to:        Principal Quality Control Specialist

About Vedanta Biosciences:

Vedanta Biosciences is a late-stage biopharmaceutical company developing medicines for the treatment of gastrointestinal diseases. The company’s lead assets include potential first-in-class oral therapies, VE303, a Phase 3-ready candidate for recurrent C. difficile infection, and VE202, in a Phase 2 trial for ulcerative colitis. Vedanta’s pipeline has been built using the company’s industry-leading product engine for the development of therapies based on defined consortia of bacteria grown from pure clonal cell banks. The product engine, supported by foundational IP, includes one of the largest libraries of bacteria isolated from the human microbiome, vast clinical datasets, proprietary capabilities in consortium design, and end-to-end CGMP manufacturing capabilities at commercial launch scale.

The Role:

The position directly supports Vedanta’s in-house cGMP manufacturing capabilities including programs in multiple phases of development. 

This role will be focused on supporting environmental monitoring and quality data review, with the opportunity to be involved in other aspects of quality control work.

A successful candidate for this role will have strong attention to detail, good organizational skills, and be a quick learner. Previous experience with environmental monitoring, personnel monitoring, general USP chapters, microbiological and chemistry testing, lab experience, aseptic technique, data review, and QMS software is valuable. This role will also work closely with other departments such as Manufacturing, Supply Chain, Quality Assurance, Technical Operations, and external vendors / contract partners to ensure timely testing and release of Vedanta products. This is a hybrid role requiring some days on site in Cambridge with flexibility to work some days from home. Occasional travel to Vedanta’s Acton, MA manufacturing facility may also be required.

Here’s What You’ll Do:

• Perform routine Environmental Monitoring (EM) and help support the EM program.
• Review contract test lab data, protocols, reports, and quality events (deviations, Out of Specification (OOS) investigations, etc.).
• Review and revise standard operating protocols (SOP), Certificates of Analysis (CoA), and reports.
• Participate in continuous improvement projects to support the growth of the team and company.
• Participate within the Quality Control (QC) team to meet group and company goals.
• Help ensure activities occur in an efficient and cGMP compliant manner.

Requirements:

• BS in a scientific discipline
• Minimum 1+ years working in a GMP environment and/or QC test lab
• Strong organizational skills, attention to detail, flexibility, and the ability to work within a team environment
• Proficient in Microsoft Outlook, Word, Excel, and lab-based data management systems
• Experience working in a laboratory, with contract test organizations (CTOs), and with vendors
• Knowledge of USP, EU, and ISO compliance
• Experience working within QMS systems, ownership of deviation investigations, OOS, CAPAs and Change Controls is a plus
• Previous experience with environmental monitoring is a plus however not required
• Experience with aseptic sampling and testing technique is a plus