Title:                  Quality Assurance Specialist, CMC

Location:           Cambridge, MA and Acton, MA

Reports to:        Director, Quality Assurance

 

The Role:

The QA CMC Specialist is responsible for performing a wide variety of activities to ensure manufacturing compliance with applicable regulatory and CGMP requirements. The primary role is to provide QA support to the set-up, execution and closure activities and processes related to product manufacture. This includes Master Batch Record changes and approvals, production batch record reviews and disposition activities and initiation and resolution of Quality Systems related to manufacturing (CAPA, Change Control, Deviations). 

Here’s What You’ll Do:

  • Support material manufacturing for clinical phase programs and manufacturing facilities.
  • Interface with Manufacturing, Technical Operations, Supply Chain, Facilities, and Quality Control to assist with QA activities.
  • Prepare and perform the manufacturing process and Quality Management Systems documentation, such as New Product Introduction, Product Change Over, facility and equipment preparation; coordinate with Manufacturing to conduct QA product changeover walkthroughs of GMP areas, cleanrooms, and room release activities.
  • Prepare documentation and records for QA disposition of Vedanta products and clinical trial materials.
  • Collaborate with other departments for investigations, risk assessments, EM alerts, change controls, deviations, and CAPAs. Implement Corrective Actions as assigned and assist in investigations.
  • Issue manufacturing batch record and logbook, completed records review, and data auditing in support of manufacturing schedules.
  • Support on going Quality activities at the Acton and Cambridge facilities.
  • Maintain production and Quality records in and support processing in computerized systems (e.g., Veeva Vault)
  • Support supplier qualification activities, including review of supplier change notifications and supplier corrective actions.
  • Update and maintain QA tracking tools and metrics and documentation.
  • Support Internal audits.

Requirements:

  • Education: Bachelor's degree with minimum of 3 years of related work experience and demonstrated knowledge of scientific principles.
  • Experience: 3+ years in GMP CMC operations: manufacturing operations, use and review of manufacturing and supporting documentation. 2+ years experience working in or with Quality Systems, such as manufacturing investigations and risk assessments, change controls, SOP writing/reviewing.
  • Overarching knowledge of GMP regulations, drug development process, regulatory product development phases, milestones and key junctures for program development (phase 1/2/3)
  • Competency using Microsoft suite (Word, Excel, PowerPoint); familiar with software based quality systems (Veeva, SAP or similar).
  • Travel to both Acton and Cambridge facilities required.
  • Personal Competencies: self-awareness, integrity, problem analysis, decision making, communication, risk management
  • Interpersonal skills: cooperation and collaboration across departments, consensus building, conflict resolution, meeting management

Written and oral communication; ability to understand complex ideas on manufacturing and technology and develop into actionable tasks and plans and communicate to others.

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.

Our Vision:

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.

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