Quality Assurance Specialist

7 days ago


Somerset, New Jersey, United States On-Board Companies Full time
About the Role

We are seeking a highly skilled Quality Assurance Specialist to join our team at On-Board Companies. As a key member of our quality team, you will be responsible for ensuring that our manufacturing processes meet the highest standards of quality and regulatory compliance.

Key Responsibilities
  • Support the development and implementation of quality policies and procedures to ensure compliance with FDA regulations and corporate requirements.
  • Coordinate the change control process to ensure that all changes are thoroughly reviewed, approved, and implemented in a timely manner.
  • Conduct risk assessments and collaborate with cross-functional teams to ensure that changes are properly documented and implemented.
  • Develop and monitor site metrics and reports for change controls and CAPAs, and provide regular updates to site leadership.
Requirements
  • Minimum Bachelor's degree in a scientific or technical field, with a graduate degree preferred.
  • At least 3 years of experience in quality assurance in the pharmaceutical industry, with cross-functional experience in engineering, technical operations, regulatory affairs, or product development.
  • Working knowledge of FDA and applicable non-US regulations, guidance, and industry standards.
  • Experience with process validation, equipment qualification, and regulatory requirements for product submissions.
  • Excellent analytical, coordination, and influential skills, with the ability to persuade cross-functional teams to achieve results.


  • Somerset, New Jersey, United States On-Board Companies Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at On-Board Companies. As a key member of our quality team, you will be responsible for ensuring that our manufacturing processes meet the highest standards of quality and regulatory compliance.Key ResponsibilitiesSupport the development and implementation of quality...


  • Somerset, New Jersey, United States Omni Inclusive Full time

    Position: Manual QA TesterOverview:We are seeking a dedicated Manual QA Tester who possesses strong SQL query writing skills. The ideal candidate will have a robust skill set in software quality assurance and a passion for ensuring high-quality software products.Key Responsibilities:Conduct thorough testing of software applications to identify defects and...


  • Somerset, New Jersey, United States Omni Inclusive Full time

    Position: Manual QA TesterOverview:We are seeking a skilled Manual QA Tester who is proficient in writing SQL queries. The ideal candidate will have a strong background in software quality assurance and a passion for ensuring high-quality software products.Key Responsibilities:Conduct thorough testing of software applications to identify defects and ensure...


  • Somerset, New Jersey, United States Synerfac Full time

    Quality Inspector Job DescriptionWork for a Central New Jersey area company that produces electro-mechanical power connection products.Key Responsibilities:Conduct thorough inspections of materials, components, and finished products according to defined inspection procedures and quality criteria.Identify and document defects, deviations, and non-conformities...


  • Somerset, New Jersey, United States smart techlink Full time

    Job OverviewWe are seeking a skilled Manual QA Tester to join our dynamic team. The ideal candidate will possess a strong background in software quality assurance and a passion for ensuring the highest quality in software products.Key ResponsibilitiesConduct thorough manual testing of software applications to identify defects and ensure quality...


  • Somerset, New Jersey, United States Omni Inclusive Full time

    Manual QA TesterPlease look for the resource who can write SQL queries. Share the skill matrix. Skill Years Manual Q SQL UnixRequired Skills:Bachelor's degree or equivalent working experienceMinimum of five (5) years of SW QA experienceExperience with Open/Closed Payment Transit Systems (TVM, TOM, ATM, Contactless devices, Smart cards) is highly...


  • Somerset, New Jersey, United States LanceSoft, Inc. Full time

    Position: Quality Assurance EngineerLocation: RemoteDuration: ContractShift: Standard Business HoursRole Overview:We are looking for a skilled Quality Assurance Engineer to enhance our quality engineering practices. This role is crucial in ensuring that our products meet the highest standards of quality and reliability. As a key contributor, you will work...

  • Validation Engineer

    2 weeks ago


    Somerset, New Jersey, United States System One Holdings, LLC Full time

    About the Role:We are seeking a highly skilled Validation Engineer to join our team at System One Holdings, LLC. As a key member of our Quality Assurance department, you will be responsible for ensuring the validation of our manufacturing processes and equipment.Key Responsibilities:Validation Protocol Development: Develop and implement validation protocols,...


  • Somerset, New Jersey, United States smart techlink Full time

    Job OverviewWe are seeking a dedicated Manual QA Tester to join our team. The ideal candidate will possess a strong background in software quality assurance and a passion for ensuring the highest quality in software products.Key ResponsibilitiesThe Manual QA Tester will be responsible for:Conducting thorough manual testing of software applications to...


  • Somerset, New Jersey, United States Eateam Full time

    Job OverviewWe are seeking a dedicated Mobile Quality Assurance Engineer to join our team at Eateam. The ideal candidate will play a crucial role in ensuring the quality and performance of our mobile applications and systems.Key ResponsibilitiesDevelop and implement testing scripts based on feature outlines, user stories, and design specifications.Create and...


  • Somerset, New Jersey, United States PIM Brands , LLC Defunct Full time

    Job OverviewWe are seeking a dedicated Quality Control Inspector to join our Quality Assurance team. This role is essential in ensuring that our products meet the highest standards of quality and safety. Job LocationSomerset - Somerset, NJPosition TypeFull TimeJob CategoryQA - Quality ControlKey ResponsibilitiesConduct routine inspections and testing of...


  • Somerset, New Jersey, United States Tekfortune Inc Full time

    Job Title: Junior QA EngineerTekfortune Inc is a leading consulting firm specializing in permanent, contract, and project-based staffing services for top organizations across various industries. In today's fast-paced economic landscape, virtual recruiting and remote work are crucial for the future of work. Our staffing experts can help you find the best job...


  • Somerset, New Jersey, United States Syneos Health inVentiv Health Commercial LLC Full time

    Position OverviewThe Senior Manager, Quality Assurance in Commercial Operations is a seasoned quality professional within the life sciences and healthcare sectors, tasked with enhancing and sustaining a robust Quality Management System (QMS) for the Commercial segment of the organization. This role is pivotal in driving significant quality initiatives,...


  • Somerset, New Jersey, United States Legend Biotech US Full time

    Job SummaryLegend Biotech US is seeking a highly skilled Manager/Sr. Manager, Quality Assurance and Compliance to join our Regulatory team in Somerset, NJ. As a key member of our team, you will be responsible for ensuring the quality and compliance of our nonclinical studies, maintaining a compliant quality system, and overseeing laboratory processes.Key...

  • Manual QA Tester

    2 weeks ago


    Somerset, New Jersey, United States Omni Inclusive Full time

    About the Role:We are seeking a highly skilled Manual QA Tester to join our team at Omni Inclusive. As a Manual QA Tester, you will play a critical role in ensuring the quality of our software applications.Key Responsibilities:Manual Testing: Conduct thorough manual testing of software applications to identify defects and ensure they meet the required...


  • Somerset, New Jersey, United States Terumo Full time

    Terumo Medical Corporation (TMC) is at the forefront of developing, producing, and distributing a comprehensive range of high-quality medical devices that cater to various sectors within the healthcare industry. Our commitment lies in delivering exceptional products, alongside robust training and educational programs that yield significant economic benefits,...


  • Somerset, New Jersey, United States Paragon Staffing, LLC Full time

    Job OverviewParagon Staffing, LLC is dedicated to linking job seekers with employers looking for temporary, contract, or permanent roles.Position Summary:The Quality Assurance Auditor is responsible for overseeing testing processes to ensure that products align with established standards of quality and performance. This role involves conducting regular...


  • Somerset, New Jersey, United States Paragon Staffing, LLC Full time

    Job OverviewParagon Staffing, LLC is dedicated to connecting talented individuals with employers in need of skilled professionals for various positions.Position Summary:The Quality Assurance Auditor plays a crucial role in monitoring and assessing product quality to ensure compliance with established standards. This includes conducting regular inspections...


  • Somerset, New Jersey, United States Insight Global Full time

    Position: Business Analyst - Returns Operations SpecialistLocation: Somerset, NJ - 3x per weekContract Duration: 18 months (with potential for extension)Qualifications:High School diploma required; Bachelor's degree preferred.Essential Skills:Exceptional technical and analytical capabilitiesExcellent verbal and written communication skillsAdvanced...


  • Somerset, New Jersey, United States Terumo Medical Corporation Full time

    Position Overview:The Regulatory Compliance Specialist will assess the existing regulatory frameworks and devise strategies for Terumo's medical devices and initiatives, ensuring adherence to necessary regulations. The complexity of this role will fluctuate based on the scope of projects and the various regulatory environments involved. This position is...