Contract - Quality Control Specialist

Title:                   Quality Control Specialist

Location:           Cambridge, MA

Reports to:        Principal Quality Control Specialist

The Role:

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

Previous experience with general USP microbiological and chemistry testing/data review, QMS software, aseptic technique, environmental monitoring and personnel monitoring preferred.  The individual will also work closely with other departments such as Manufacturing, Supply Chain, Quality Assurance, 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 investigations, etc.)
• Author and revise SOPs, CoAs, 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
• Help ensure activities occur in an efficient and cGMP compliant manner

Requirements:

• BS in a Scientific Discipline
• Minimum 3+ 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
• Direct experience with aseptic sampling and testing techniques
• Strong organizational skills, attention to detail, flexibility, and the ability to work within a team environment
• Experience working with CTOs, vendors and relationship management
• Proficient in Outlook, MS Word, Excel, and lab-based data management systems
• Knowledge of USP, EU, ISO compliance

Why join Vedanta Biosciences:

Vedanta is pioneering the development of a new class of therapies 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. Vedanta was founded by PureTech Health and a team of world-renowned experts in immunology and microbiology. 

We invite you to explore our site to learn more about our company and how our discovery platform enables identification of bacterial consortia with drug-like properties and their manufacture to GMP standards.

Vedanta is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vedanta will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Vedanta Biosciences requires all employees to be fully vaccinated against COVID-19 and newly hired employees must be fully vaccinated prior to their employment start date. Vedanta Biosciences will consider accommodations for individuals who are unable to be vaccinated against COVID-19 due to a qualifying medical condition or disability or a sincerely held religious objection.