Contract - Quality Control Specialist

Title:                  Contract - Quality Control Specialist

Location:           Cambridge, MA

Reports to:        Associate Director, Quality Control

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:

This position directly supports Vedanta’s GMP manufacturing capabilities including programs in multiple phases of development. The role will also include final product release testing.

The quality control specialist exercises judgment within defined procedures and practices to determine appropriate action. The successful candidates applies learned techniques and contributes to analysis and investigation to solve problems. This role normally receives little instruction on day-to-day work and general instructions on new assignments.

Previous experience with hands-on laboratory testing in a microbiology laboratory, aseptic technique, and general USP microbiological and chemistry testing/data review are 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.

Here’s What You’ll Do:

• Perform microbiology testing to support release and stability of Vedanta products.
• 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
• Participate within the QC team to meet group and company goals

Requirements:

• BS in a Scientific Discipline
• Minimum 3+ years working in a GMP Quality Control test lab
• Experience with PCR testing
• 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
• Experience working within QMS systems, deviation investigations, OOS, CAPAs and Change Controls
• Experience with QC continuous improvement projects; project management skills a plus
• Proficient in Outlook, MS Word, Excel, and lab-based data management systems
• Knowledge of USP, EU, ISO compliance