Quality Assurance Specialist

4 days ago


Watertown, Massachusetts, United States Advantage Technical Full time
Job Title: Quality Systems Specialist

At Advantage Technical, we are seeking a highly skilled Quality Systems Specialist to join our team. This role will be responsible for supporting Global Quality Systems and their operations in ensuring compliance and fit for intended use per applicable global SOPs.

Key Responsibilities:
  • Support the governance of Quality System applications, including harmonization of processes across sites.
  • Ensure the system is maintained in a validated state by participating in periodic user access reviews, ongoing change management, business administration, and deviations/CAPAs associated with Quality Systems.
  • Collaborate with cross-functional teams to ensure compliance with US FDA and European regulatory requirements and GAMP.
  • Develop and maintain knowledge of Regulatory Compliance and ICH Guidelines.
  • Provide support for the implementation and maintenance of Quality System processes.
Requirements:
  • Bachelor's degree or higher in a relevant computer/technical/quality/scientific discipline.
  • Minimum of 3-6 years of experience in a high-volume commercial/clinical pharma/healthcare facility.
  • Proficient in MS Word, Excel, and Quality System processes.
  • Experience with Veeva Vault Quality Docs, TrackWise, and ComplianceWire is a plus.
  • Strong understanding of US FDA and European regulatory requirements and GAMP.
  • Knowledge of Regulatory Compliance and ICH Guidelines.
What We Offer:
  • A dynamic and collaborative work environment.
  • Opportunities for professional growth and development.
  • A competitive salary and benefits package.


  • Watertown, Massachusetts, United States Talnt Full time

    Job Title: Quality Assurance SpecialistAt Talnt, we are seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality and safety of our products, adhering to regulatory requirements and industry standards.Key Responsibilities:Develop and implement quality assurance...


  • Watertown, Massachusetts, United States Talnt Full time

    Job Title: Quality Assurance SpecialistAt Talnt, we are seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of quality and safety in our food manufacturing processes.Key Responsibilities:Develop and maintain internal policies and...


  • Watertown, Massachusetts, United States Talnt Full time

    Job Title: Quality Assurance SpecialistAt Talnt, we are seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our quality team, you will be responsible for developing and implementing quality assurance programs to ensure compliance with Safe Quality Food (SQF) standards and good manufacturing practices.Key...


  • Watertown, Massachusetts, United States Talnt Full time

    Job SummaryThe Quality Assurance Specialist is responsible for developing, maintaining, and implementing quality assurance programs to ensure compliance with Safe Quality Food (SQF) standards and good manufacturing practices.Key ResponsibilitiesDevelop and maintain internal policies and procedures to meet SQF requirements.Track, review, and analyze product...


  • Watertown, Massachusetts, United States Sequoia Biotech Consulting Full time

    Job Title: Quality Assurance SpecialistSequoia Biotech Consulting is seeking a seasoned Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for managing, administering, developing, and delivering quality programs and oversight with various therapeutic products within the life sciences industry.Key...


  • Watertown, Massachusetts, United States Boston Children's Hospital Full time

    Job SummaryThe Sterile Processing Quality Assurance Specialist 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, documents...


  • Watertown, Massachusetts, United States Danaher Corporation Full time

    Job Title: Quality Assurance CoordinatorJoin Danaher Corporation, a leading life sciences company, as a Quality Assurance Coordinator. In this role, you will be responsible for ensuring the quality of our products and services, working closely with our Quality Assurance Manager and the Quality & Operational Excellence department.Key Responsibilities:Assist...


  • Watertown, Massachusetts, United States Source Recruitment Solutions Full time

    Quality Assurance Manager Job DescriptionWe are seeking an experienced Quality Assurance Manager to join our team at Source Recruitment Solutions. As a Quality Assurance Manager, you will be responsible for ensuring the quality and safety of our client's food products.Key Responsibilities:Develop and implement quality control programs to ensure compliance...


  • Watertown, Massachusetts, United States Liberty Personnel Services, Inc Full time

    Job Title: Quality Assurance DirectorWe are seeking a highly experienced Quality Assurance Director to join our team at Liberty Personnel Services, Inc.The successful candidate will be responsible for ensuring the highest standards of quality and food safety in our manufacturing processes.Develop and implement quality control procedures to ensure compliance...


  • Watertown, Massachusetts, United States Affini-T Full time

    About Affini-T TherapeuticsA clinical stage biotechnology company focused on building a "best-in-class" TCR therapy platform. Our innovative method of discovering high affinity TCRs specific to oncogenic driver mutations is used to develop solid tumor therapies. Through the application of gene editing and synthetic biology, we focus on enhancing T-cell...


  • Watertown, Massachusetts, United States Danaher Corporation Full time

    Job Title: Quality Assurance CoordinatorAt Danaher Corporation, we are seeking a highly skilled Quality Assurance Coordinator to join our team. As a Quality Assurance Coordinator, you will play a critical role in ensuring the quality of our products and services.Key Responsibilities:Assist with internal audits of Manufacturing/Logistics functions to verify...


  • Watertown, Massachusetts, United States Source Recruitment Solutions Full time

    Quality Assurance Manager Job DescriptionWe are seeking an experienced Quality Assurance Manager to join our team at Source Recruitment Solutions. The successful candidate will be responsible for ensuring the highest quality standards in our food manufacturing plant.Key Responsibilities:Develop and implement quality control programs to ensure compliance with...


  • Watertown, Massachusetts, United States Affini-T Full time

    About Affini-T TherapeuticsA clinical stage biotechnology company focused on developing a "best-in-class" TCR therapy platform. Our innovative approach involves discovering high-affinity TCRs specific to oncogenic driver mutations to develop solid tumor therapies. By leveraging gene editing and synthetic biology, we enhance T-cell fitness to overcome the...


  • Watertown, Massachusetts, United States Affini-T Full time

    About Affini-T Therapeutics Affini-T Therapeutics is a clinical stage biotechnology company focused on developing innovative TCR therapy platforms. Our approach involves discovering high-affinity TCRs specific to oncogenic driver mutations to create solid tumor therapies. By leveraging gene editing and synthetic biology, we enhance T-cell fitness to overcome...


  • Watertown, Massachusetts, United States Terex Full time

    Job Description:The Quality Technician team plays a crucial role in ensuring the quality of our products by conducting final inspections and testing to verify compliance with quality standards. They develop and implement testing procedures to verify quality and compliance of completed products. The team ensures that quality testing is conducted on a...


  • Watertown, Massachusetts, United States Terex Full time

    Job Description:Position Overview:The Quality Technician team is responsible for ensuring the quality of products by conducting final inspections or testing to verify compliance with quality standards and specifications. They develop and implement testing procedures to verify quality and compliance of completed products.Key Responsibilities:Conduct final...


  • Watertown, Massachusetts, United States Cirkul Inc Full time

    Job DescriptionCirkul Inc is seeking a Quality Engineering Technician to join our team. As a Quality Engineering Technician, you will work closely with the Quality and Product team in running new tests to determine product performance, along with qualifying new and existing products.Key Responsibilities:Develop and implement test procedures to ensure product...


  • Watertown, Massachusetts, United States Massachusetts Medical Society Full time

    Job Title: Quality Assurance Tester and Analyst Co-opJob Description:The Massachusetts Medical Society (MMS) is a professional association for physicians and medical students. We are dedicated to educating and advocating for the physicians of Massachusetts and patients locally and nationally. Our mission is to advance medical knowledge from research to...


  • Watertown, Massachusetts, United States The Judge Group Full time

    Job Title: Test EngineerJob Summary:The Judge Group is seeking a skilled Test Engineer to join their team for a long-term contract opportunity. As a Test Engineer, you will be responsible for overseeing all testing activities for one or more products in development.Key Responsibilities:* Collaborate with the Test Manager to define testing requirements and...


  • Watertown, Massachusetts, United States Heritage Senior Living Full time

    Job Title: Clinical and Quality SpecialistWe are seeking an experienced Clinical and Quality Specialist to join our team at Heritage Senior Living. As a key member of our corporate support team, you will play a vital role in ensuring the highest quality of care and services for our residents.Key Responsibilities:Support the implementation and monitoring of...