Title: Contract - Quality Assurance Specialist, CMC Location: Cambridge, MA and Acton, MA Reports to: Supervisor, Quality Assurance 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 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). This role requires onsite work Monday through Friday.
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.Role Complexity and Problem Solving: In this role, you will:
Wok on problems of limited scope, with opportunity to expand level of assignments based upon performance.Analyze situations or data from which answers can be readily obtained as part of compliance responsibilities, standard practices, and procedures.Have your work reviewed periodically based on a set of defined procedures or precedence.Receive general instruction on work and new assignments. Collaboration and Interaction Expectations: In this role, you will:
Develop stable working relationships internally.Exchange standard/basic information with colleagues, immediate supervisor, project leaders, and other professionals in the team/group. 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 managementInterpersonal skills: cooperation and collaboration across departments, consensus building, conflict resolution, meeting managementWritten and oral communication; ability to understand complex ideas on manufacturing and technology and develop into actionable tasks and plans and communicate to others. Our Vision: Pioneering microbiome therapeutics by using Defined Bacterial Consortia to transform the lives of patients with serious diseasesVedanta 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.
