We have other current jobs related to this field that you can find below

  • Quality Assurance Associate III

    3 months ago

    Waltham, United States PSG Global Solutions Careers Full time

    Apply now and our proprietary system will quickly have you in front of a live recruiter. The Opportunity Description We're looking for a Quality Assurance Associate III, working in Pharmaceuticals and Medical Products industry in 153 2nd Avenue, Waltham, Massachusetts, 02451, United States. Responsibilities: Support quality oversight across GPV GBUs on PV...

  • Design Assurance Engineer III

    2 weeks ago

    Waltham, Massachusetts, United States Boston Scientific Full time

    Additional Location(s): N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest...

  • Senior Director, Quality Assurance

    3 months ago

    Waltham, United States TScan Therapeutics Full time

    Job DescriptionJob DescriptionPosition Summary:TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for a Dir/Sr. Director of Quality to lead Quality Assurance for in-house and virtual GMP operations supporting the company’s novel...

  • Quality Assurance Specialist

    3 days ago

    Waltham, Massachusetts, United States Aveanna Healthcare LLC Full time

    Discover Your Purpose with Aveanna Healthcare. Aveanna embodies a unique blend of compassion and dedication, creating an environment where care is delivered with a personal touch, right in the comfort of home. Experience the difference that awaits you at Aveanna. We are a healthcare organization committed to excellence in care and dedicated to the families...

  • Quality Automation Engineer III

    3 months ago

    Waltham, United States ZoomInfo Full time

    QA Engineer III Waltham Massachusetts HybridAs a Quality Assurance Engineer, you will work within a scrum team. You will be responsible for designing and implementing test solutions to measure and validate the infrastructure and functionality of ZoomInfo directories. You will report to a Manager of Quality Engineering. What you will do:  Actively...

  • Associate I, Quality Assurance

    2 weeks ago

    Waltham, Massachusetts, United States Elevatebio Full time

    ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential.The Role:ElevateBio...

  • Director Of Quality Assurance

    1 month ago

    Waltham, United States RPM ReSearch Full time

    Title: Director of Quality Assurance CDMO Location: Greater Boston, MA area Generous Relocation Assistance provided Onsite Presence Required JOB SUMMARY The Director of Quality Assurance is responsible for managing all aspects of the Quality Assurance while developing, implementing, and maintaining an effective Quality Management System under appropriate...

  • Quality Assurance Specialist

    3 days ago

    Waltham, Massachusetts, United States Convergent Dental Inc Full time

    Job OverviewPosition Summary:The Quality Technician is responsible for supporting the inspection processes, calibration initiatives, and analysis of returned products. We seek a proactive, detail-oriented individual who can work autonomously while also collaborating effectively within a team. This role will report directly to the Director of Quality...

  • Quality Assurance Engineer for Robotics

    3 days ago

    Waltham, Massachusetts, United States Boston Dynamics Full time

    Position Overview:As a Quality Assurance Engineer at Boston Dynamics, you will be a key member of our Operations division, dedicated to ensuring that our robotic products are manufactured to the highest quality standards. Key Responsibilities:Your role will involve collaborating closely with Supply Quality Engineers, Product Engineers, and the Operations...

  • Quality Assurance Specialist

    3 days ago

    Waltham, Massachusetts, United States Convergent Dental Inc Full time

    Job OverviewPosition Summary:The Quality Technician plays a crucial role in supporting the inspection processes, calibration programs, and analysis of returned products. We seek a proactive, detail-oriented individual who can work autonomously while also contributing to team objectives. This role will report directly to the Director of Quality Assurance and...

  • Quality Assurance Engineer for Suppliers

    3 days ago

    Waltham, Massachusetts, United States Convergent Dental Inc Full time

    Job OverviewConvergent Dental is at the forefront of dental innovation with our flagship product, Solea, a cutting-edge dental laser that operates without anesthesia. As we continue to lead the industry, we are seeking a dedicated professional to enhance our supplier quality processes.Position Summary:The Supplier Quality Engineer plays a pivotal role in...

  • Quality Assurance Engineer for Suppliers

    3 days ago

    Waltham, Massachusetts, United States Convergent Dental Inc Full time

    Job OverviewConvergent Dental is at the forefront of dental innovation with Solea, a cutting-edge dental laser that performs tissue cutting without the need for anesthesia. As we continue to lead the industry, we are seeking a dedicated professional to join our dynamic team.Position Summary:The Supplier Quality Engineer plays a pivotal role in overseeing...

  • Quality Assurance Engineer for Suppliers

    3 days ago

    Waltham, Massachusetts, United States Convergent Dental Inc Full time

    Job OverviewConvergent Dental has pioneered the development of Solea, a revolutionary dental laser designed to cut tissue in the oral cavity without the need for anesthesia. Solea has rapidly established itself as the leading hard and soft tissue laser in the dental industry. This is an exciting opportunity to be part of a forward-thinking organization that...

  • Senior Software Quality Assurance Engineer

    4 days ago

    Waltham, Massachusetts, United States ServiceNow Full time

    Job OverviewCompany Overview:At ServiceNow, we empower organizations to operate efficiently and effectively. Our innovative technology transforms the way businesses function, and our dedicated team is the driving force behind this transformation. We are committed to fostering an environment where creativity and collaboration thrive, enabling our employees to...

  • Manager, Clinical Quality Assurance

    3 months ago

    Waltham, United States Deciphera Pharmaceuticals Full time

    Job DescriptionJob DescriptionCompany DescriptionDeciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of...

  • Sterile Processing Quality Assurance Technician

    1 month ago

    Waltham, United States Boston Children's Hospital Full time

    General SummaryThe Sterile Processing Quality Assurance Specialist (QA) is responsible for ensuring the accuracy and proper assembly of instrument trays according to pick sheets. This role includes verifying instrument placement, checking for good working order, and preparing trays for processing. The QA specialist provides immediate feedback and coaching,...

  • Sterile Processing Quality Assurance Technician

    1 month ago

    Waltham, United States Boston Children's Hospital Full time

    General SummaryThe Sterile Processing Quality Assurance Specialist (QA) is responsible for ensuring the accuracy and proper assembly of instrument trays according to pick sheets. This role includes verifying instrument placement, checking for good working order, and preparing trays for processing. The QA specialist provides immediate feedback and coaching,...

  • Associate Director, Quality

    1 month ago

    Waltham, United States Upstream Bio Full time

    Position Summary: Upstream Bio is developing innovative therapeutics in inflammation. We are a nimble company with solid financial backing that has raised $400M from high-quality investors. We are developing a monoclonal antibody targeting validated biology and are focused on our two Phase 2 studies in asthma and chronic rhinosinusitis with nasal polyps...

  • Associate Director, Quality

    1 month ago

    Waltham, United States Upstream Bio Full time

    Position Summary: Upstream Bio is developing innovative therapeutics in inflammation. We are a nimble company with solid financial backing that has raised $400M from high-quality investors. We are developing a monoclonal antibody targeting validated biology and are focused on our two Phase 2 studies in asthma and chronic rhinosinusitis with nasal polyps...

  • Quality Improvement

    3 weeks ago

    Waltham, United States Aveanna Healthcare LLC Full time

    FIND YOURSELF HERE. Aveanna is compassion and passion rolled into one inspired purpose. It's anything you want to find and everything you're looking for. It's a place where caring is more personal, because it happens right in the comfort of home. Come see what's waiting for you when you come to Aveanna. We're a company built on compassion, excellence in...

Quality Assurance Associate III

3 months ago

Waltham, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Person in Plant for Manufacturing runs.
  • Perform lot release Quality Review of manufacturing and quality control records to ensure compliance with specifications and regulations.
  • Reviews and approves master production records for the timely initiation of GMP manufacturing activities.
  • Reviews executed batch records and related documentation, resolves compliance issues and dispositions lots of drug substance, bulk drug product, drug product and clinical materials for use in clinical trials
  • Perform lot release Quality Review of manufacturing and quality control records to ensure compliance with specifications and regulations.
  • Ensure that all requirements, as stipulated in the appropriate QTA, have been met.
  • Issue/Review documentation, i.e. Deviations, CAPAs, OOS etc., as they occur.
  • Write and revise SOP, forms, WI, and any other document types
  • ssist with internal and external audits.
  • Lead compiling data analysis and metrics for QMR, KPIs, and other reportable forums may be requested.
  • ssume additional responsibilities as assigned.
Requirements:
  • Bachelor's and/or 8+ years of relevant experience
  • Minimum 5 years of experience in Quality Assurance
  • Working knowledge and ability to apply Quality principles and cGMPs in conformance to standards, preferably gained from working in a manufacturing, QA or QC environment.
  • Demonstrated ability to interact and communicate effectively, both written and verbal, with peers, management, auditors, and consultants.
  • Must have excellent attention to detail, project and time management skills, and the ability to manage multiple priorities with aggressive timelines.
  • Working knowledge of MS Office products including Word, Excel, Outlook, PowerPoint, and Project.
  • Excellent communications skills both written and verbal.
  • Effective time management and organizational skills.
  • Strong attention to details and ability to lead others in a team setting.
  • bility to gown and enter clean rooms
  • Perform review of Batch records and associated documents in support of the release of a product.
  • Review of Analytical data
  • Perform QA presence on the floor/person in the plant
  • Ensure that documentation and operations meet established requirements of cGMPs, Internal
  • SOPs, and company policies.
  • Draft and revise procedures as required.
  • Performs work that requires decision-making and the consistent exercise of independent judgment and discretion