Senior QA Specialist

5 days ago


Étreux, Hauts-de-France, United States Foundation Medicine Full time

Job Title: Senior QA Specialist

About the Job:

  • The Senior QA Specialist, Document Control works as part of a new product team at Foundation Medicine to improve blood-based cancer diagnostic capabilities.
  • This role involves leading programs, mentoring peers, developing and implementing regulation-adherent processes, and improving quality functions.
  • The Senior Specialist is responsible for inspections, monitoring, auditing, revising quality standards, and recommending process improvements.

Key Responsibilities:

  • Act as administrative leader for electronic Document Management System (eDMS) Veeva Vault.
  • Coordinate all aspects of eDMS operation, implementation, and maintenance for controlled issue, retrieval, archiving of regulated documents.
  • Support new product development document creation project, collaborating with the team.
  • Maintain quality and detail in document creation and management.
  • Responsible for maintaining, updating, and versioning of all policies and procedures and forms.
  • Perform document quality checks on all controlled documents.
  • Coordinate periodic review for required documents.

Qualifications:

  • Bachelor's degree or related field with 5+ years experience in medical device, diagnostics, clinical laboratory or biopharmaceutical industry - preferably in a QA environment.
  • Experience working with electronic document management and quality management systems highly preferred.
  • Previous Document Control or Record Management experience required.
  • Exposure to regulatory compliance knowledge including GMP, ISO 13485, ISO 15189, CAP/CLIA, NYS, states, GCP, IVDR, and 21 CFR Part 11 Compliance.

Salary Estimate: $80,000-$120,000 per year.


  • Senior QA Manager

    2 weeks ago


    Étreux, Hauts-de-France, United States Diverse Lynx Full time

    Job Title: Senior QA ManagerWe are seeking a highly skilled and experienced Senior QA Manager to join our team at Diverse Lynx LLC.Job Description:The ideal candidate will have a proven track record of managing software development projects, ensuring high-quality deliverables, and collaborating with cross-functional teams. Key responsibilities include...


  • Étreux, Hauts-de-France, United States TWO95 International Full time

    TWO95 International is seeking an experienced QA Automation Specialist for a 6+ month contract position in Boston, MA.">">About the Job:">As a QA Automation Specialist, you will be responsible for designing and implementing automated testing solutions using Selenium and Appium. You will work closely with the development team to ensure high-quality software...


  • Étreux, Hauts-de-France, United States Motion Recruitment Partners LLC Full time

    Job Summary: Motion Recruitment Partners LLC is seeking a highly skilled Senior QA Automation Engineer with hands-on experience in SAP Fieldglass testing. The ideal candidate will have strong object-oriented coding skills and at least 5 years of experience working with SAP products.


  • Étreux, Hauts-de-France, United States Escher Group Full time

    Escher Group OverviewWe are a global company that powers the world's first and last mile deliveries, helping Posts connect nearly 1 billion consumers with global ecommerce networks.About the JobThis is a full-time position for a Senior QA Specialist to join our team in Boston. As a QA Specialist, you will be responsible for executing different testing...


  • Étreux, Hauts-de-France, United States Verista Full time

    Job Summary:">We are seeking a skilled Senior Quality Specialist to join our team at Verista. This role will be responsible for providing quality oversight and support to site Cell and Gene Therapy operations, including manufacturing operations, analytical laboratory, materials management, and facility/engineering groups.">About Verista:">Verista's 600...


  • Étreux, Hauts-de-France, United States Foundation Medicine Full time

    Job OverviewWe are seeking an experienced Senior QA Specialist, Document Control to join our team at Foundation Medicine. This role plays a critical part in ensuring the quality and compliance of our document control processes.About the JobThis position will be responsible for leading programs, mentoring peers, developing and implementing regulation-adherent...


  • Étreux, Hauts-de-France, United States Motion Recruitment Partners LLC Full time

    About the Opportunity: Are you a seasoned QA Automation Engineer looking for a new challenge? We're seeking a talented individual to join our team as a Senior QA Automation Engineer specializing in SAP Fieldglass. This is a fully remote position based in the US, offering a competitive hourly rate of $60-$80/hour.As a key member of our team, you'll work on...


  • Étreux, Hauts-de-France, United States Disability Solutions Full time

    About the RoleThe Senior QA Specialist, Document Control plays a vital role in our new product team at Disability Solutions, focusing on improving blood-based cancer diagnostic capabilities. This position requires a strong background in quality assurance and regulatory compliance.Key ResponsibilitiesLead programs, mentor peers, and develop...


  • Étreux, Hauts-de-France, United States Disability Solutions Full time

    Job OverviewThe Senior QA Specialist, Document Control is a critical role at Disability Solutions, responsible for leading programs, mentoring peers, and developing regulation-adherent processes. This position plays a key part in improving quality functions, formalized procedures, operations, and systems.Key ResponsibilitiesElectronic Document Management...


  • Étreux, Hauts-de-France, United States Escher Group Ltd. Full time

    Job Title: Lead Quality Assurance SpecialistAt Escher Group Ltd., we are seeking a highly skilled Senior QA Engineer to join our team. As a Senior QA Engineer, you will play a critical role in ensuring the quality of our software products by executing various testing activities from preparation of test cases to testing execution.Responsibilities:Analyze and...


  • Étreux, Hauts-de-France, United States Motion Recruitment Full time

    Job OverviewWe are seeking a highly skilled Senior QA Automation Engineer to join our team. As a key member of our automation team, you will be responsible for developing and maintaining automated testing frameworks using Java and Selenium.


  • Étreux, Hauts-de-France, United States Apryse Full time

    About Apryse">Apryse is a leading provider of cutting-edge technology solutions that empower our clients to achieve their goals. Our company has a broad international portfolio of combined companies, products, and leading technologies, actively changing the way the world works with documents to make work better and life simpler.Job Description:We are seeking...


  • Étreux, Hauts-de-France, United States Verista Full time

    ResponsibilitiesThe Senior Quality Specialist will be responsible for:Providing quality oversight and support to site Cell and Gene Therapy operationsLeading QA efforts to establish new programs supporting Drug Product facility start-upReviewing batch data, including batch records, deviations, in-process data, EM data, and QC release testingApproving COAs...


  • Étreux, Hauts-de-France, United States TechnoGen Full time

    About UsTechnoGen is a leading technology company that provides innovative solutions to businesses worldwide. We are committed to delivering high-quality applications that meet the evolving needs of our clients.Job Description: Senior Java and Scala DeveloperEstimated Salary: $150,000 per yearOverviewAs a senior Java and Scala developer at TechnoGen, you...


  • Étreux, Hauts-de-France, United States Disability Solutions Full time

    Job DescriptionWe are seeking a highly skilled Senior QA Specialist, Document Control to join our team at Disability Solutions. As a key member of our new product team, you will be responsible for leading programs, mentoring peers, and developing regulation-adherent processes.ResponsibilitiesAct as the administrative leader for electronic Document Management...


  • Étreux, Hauts-de-France, United States Slalom Full time

    About the Opportunity:We are seeking a Quality Assurance Specialist to join our team at Slalom. As a Quality Assurance Specialist, you will be responsible for defining and delivering functional quality assurance across all types of projects and technology stacks. This role requires strong analytical and problem-solving skills, as well as excellent...


  • Étreux, Hauts-de-France, United States Trillium Staffing Full time

    Senior Quality Assurance ExpertThe Trillium Staffing company is seeking a highly skilled Senior Quality Assurance Expert in the Boston, MA area. This hybrid position involves providing technical expertise in test automation to support the software development team's efforts to deliver defect-free code.As a Senior Quality Assurance Expert, you will be...


  • Étreux, Hauts-de-France, United States Franklin Fitch Full time

    Senior DevOps Specialist - Boston, MAFranklin Fitch, a rapidly growing technology firm, is seeking a senior-level DevOps Specialist to join their team in Boston, MA. As a key member of the organization, you will be responsible for designing and implementing DevOps practices, ensuring seamless integration and deployment of applications. Your expertise in...


  • Étreux, Hauts-de-France, United States American Iron & Metal Full time

    Exciting Career Opportunity: Senior Metal Procurement SpecialistWe are seeking a dynamic and results-driven Senior Metal Procurement Specialist to join our team at American Iron & Metal. This is an exceptional chance to take your career to the next level in the metal recycling industry.


  • Étreux, Hauts-de-France, United States Verista Full time

    Our team at Verista is committed to delivering exceptional results and driving business success through our passion for quality and innovation. As a Senior Quality Specialist, you will have the opportunity to contribute to our mission by leading QA efforts, reviewing batch data, and determining product disposition acceptability. With your expertise in GMP...