Title: Contract – Quality Control Associate/Senior Quality Control Associate
Location: Cambridge, MA
Reports to: Quality Control Supervisor
Weekly Onsite Requirements: 2-3 days onsite/week
The Senior/Quality Control Associate 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:
- Perform routine EM/PM in support of GMP manufacturing of Vedanta in house products
- Review contract test lab data, protocols, reports, and quality events (deviations, OOS etc.)
- Authoring and revising 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
- BS in a Scientific Discipline
- Minimum 3 years working in a GMP Quality Control test lab
- 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
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.
We are harnessing the human microbiome to enable a new drug modality based on rationally defined bacterial consortia
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.