QA / Ra Assistant

2 weeks ago


Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Immunodiagnostics System Ltd Full time

QA / RA Assistant:

QA/RA - UK:

Department:
QA/RA

Type:
Permanent

Based:
Hybrid

Salary:

Closing Date: 04/07/2024

IDS is a leading in-vitro diagnostic solution provider to the clinical laboratory market. We develop, manufacture and market innovative immunoassays and automated immunoanalyser technologies to provide improved diagnostic outcomes for patients.

IDS Boldon is the global IDS Headquarters occupying a single, multi-disciplined site.

The site focuses on the manufacture and distribution of manual Immunoassay products.

On site Purchasing, Logistics, Production, Quality Control and Process Development departments manage the supply chain, supported by local Sales Support, Quality Assurance, Regulatory Affairs and Finance departments.

As Group Headquarters, IDS Boldon also houses all head office functions.


Are you passionate about quality assurance and regulatory affairs? We have an exciting opportunity for you to play a vital role in maintaining our Quality Management System.

As part of our dedicated team, you will manage key quality systems and processes, ensuring excellence in everything we do.

If you're ready to make a difference in the world of healthcare diagnostics, this could be an excellent opportunity for you

  • Manage the Quality Management System according to international standards for IVD product manufacture at IDS Boldon.
  • Administer document control, including periodic reviews, updates, and archiving.
  • Maintain Device Master Records (DMRs) and related documentation.
  • Oversee updates and issuance of Information for Use (IFU) and Safety Data Sheets (SDSs).
  • Compile data for Site Quality Meetings and Quality Management Reviews.
  • Administer the Customer Notification system and prepare Post Market Surveillance Reports.
  • Measure and report Quality performance indicators for Change Requests, CAPA, Deviations, and Complaints.
  • Support internal and external audits.
  • Assist with regulatory documentation, including MHRA submissions, Tenders, and Questionnaires.
  • Administer the online training system and support staff training.
  • Promote quality awareness throughout the company.

Qualifications
OR- Qualified by experience (minimum 2 years' experience in a similar role)

Skills & Knowledge

  • A good understanding of Microsoft Word, Excel and content / database systems such as Access, share point
  • Knowledge of working within Quality Management Systems and their operation
  • Good attention to detail; and good communication skills
  • Ability to work as part of a team, departmentally and interdepartmentally
  • Ability to work under pressure and to strict deadlines
  • Good organisation and influencing skills

Experience

  • At least 1 years' experience in an administrator or related role within IVD, medical device or other regulated industry

Our Values
-
Embrace the unknown - every big idea starts with a bold, fundamental question: What If?
-
Passion for people - our people are our greatest asset and fuel our success in service of humanity.
- ** Collabora
  • Ra Officer

    2 weeks ago


    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Leica Biosystems Full time

    Leica Biosystems' mission of "Advancing Cancer Diagnostics, Improving Lives" is at the heart of our corporate culture. We're a global leader in cancer diagnostics with the most comprehensive portfolio from biopsy to diagnosis. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. Our associates know...

  • QA Team Lead

    2 weeks ago


    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Xplor Full time

    Company DescriptionAt Xplor, we help businesses thrive by making life simple for daily activities with a recurring nature. We do that by offering smart software, payments, and commerce-enabling solutions across five "everyday life" verticals: Education, Health and Fitness, Boutique Wellness, Field Services and Personal Services.Join our Xplor Pay team as a...

  • QA Tester

    2 weeks ago


    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Manpower Group (UK) Full time

    QA Tester Remote / Newcastle The ideal candidate will have active SC Clearance or be eligible to undergo SC Clearance. We are actively looking to secure a QA Tester to join Experis. Experis Consultancy is a Global entity with a well-established team with over 1000 consultants on assignment across 20 clients globally. Our UK operation is growing and has...


  • Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom QA Ltd Full time

    Employer description:Mayborn Group is a Global company, so the support extends across all our Global sites and users.About the role:The apprentice will be supporting the creation of Business Intelligence reports from defined business requirements, assisting in the gathering of business requirements, general user support for the Mayborn Business Intelligence...


  • Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom QA Apprenticeships Full time

    Employer description:Welcome to FSNE MedicalIf. If you are searching for a fully qualified and responsive team of ambulance drivers in the North East, our friendly and dedicated team is happy to provide our assistance. FSNE Medical is based in Northumberland with the facilities to operate nationwide.Overview:You will have the opportunity to efficiently plan...

  • Marketing Apprentice

    2 weeks ago


    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom QA Apprenticeships Full time

    Employer description:Home Store Living is a family-run luxury furniture store with a goal to make unique, designer home decor accessible for everyone. We're all about embracing all things unusual and wonderful in a way that feels beautifully designed and luxurious. We handpick all of our products from high quality, trusted suppliers and manufacturers to find...


  • Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom QA Ltd Full time

    Employer description:About Elevate:Elevate is a home to those of us who dedicate our multi-disciplinary careers and diverse experiences to trying to improve the legal industry. It is our place to 'make a dent in the universe.'We enjoy and value our relationships with like-minded people throughout the legal community and we find deep satisfaction in seeing...


  • Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Newcastle University Full time

    Company description:We are a world class research-intensive university. We deliver teaching and learning of the highest quality. We play a leading role in economic, social and cultural development of the North East of England. Attracting and retaining high-calibre people is fundamental to our continued success.Job description:The RoleWe are seeking to...

  • Research Associate

    2 weeks ago


    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom HistoCyte Laboratories Ltd Full time

    The role:As a Research Associate, you will drive and manage projects from concept to production. Your skill set must include exceptional aseptic technique in tissue culturing, immunohistochemistry, and microtomy. You will be primarily focused on identifying cell lines for immunohistochemistry and in situ hybridisation controls. Your work will adhere to...

  • QA Officer

    2 weeks ago


    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom NCFE Full time

    Overview:Contract:Fixed-term, 6 months**Location:Hybrid working - Head office: Quorum Business Park, Newcastle upon TyneHours per week: 37Salary:Up to 27,040 per annum, depending on experience**Shape real change with an NCFE careerImagine a career where your contributions affect not only what people learn, but the way that learning is developed and...


  • Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Newcastle University Full time

    Company description:We are a world class research-intensive university. We deliver teaching and learning of the highest quality. We play a leading role in economic, social and cultural development of the North East of England. Attracting and retaining high-calibre people is fundamental to our continued success.Job description:Salary: Research Assistant:...

  • Research Assistant

    4 weeks ago


    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Newcastle University Full time

    Company description:We are a world class research-intensive university. We deliver teaching and learning of the highest quality. We play a leading role in economic, social and cultural development of the North East of England. Attracting and retaining high-calibre people is fundamental to our continued success.Job description:The RoleAs part of our...

  • Research Assistant

    1 month ago


    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Newcastle University Full time

    Company description:We are a world class research-intensive university. We deliver teaching and learning of the highest quality. We play a leading role in economic, social and cultural development of the North East of England. Attracting and retaining high-calibre people is fundamental to our continued success.Job description:The RoleAs part of our...


  • Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Newcastle University Full time

    Salary:Research Assistant: £31,396 to £32,982 per annumResearch Associate: £33,966 to £44,263 per annumSenior Research Associate: £45,585 to £48,350 per annumNewcastle University is a great place to work, with excellent benefits. We have a generous holiday package; plus the opportunity to buy more, great pension schemes and a number of health and...


  • Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Newcastle University Full time

    Salary:Research Assistant: £31,396 to £32,982 per annumResearch Associate: £33,966 to £44,263 per annumNewcastle University is a great place to work, with excellent benefits. We have a generous holiday package; plus the opportunity to buy more, great pension schemes and a number of health and wellbeing initiatives to support you.Closing Date: 03 July...


  • Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Northumbria University Full time

    About the roleJoining a dynamic, multi-disciplinary team, you will support the project Investigators to drive forward research activities for the "Sustainable Style for Clean Growth: Innovating Textile Production through Engineering Biology" project. We're in search of two dedicated, motivated, and innovative researchers to join the Living Construction...


  • Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Northumbria University Full time

    About the roleJoining a dynamic, multi-disciplinary team, you will support the project Investigators to drive forward research activities for the "Sustainable Style for Clean Growth: Innovating Textile Production through Engineering Biology" project. We're in search of two dedicated, motivated, and innovative researchers to join the Living Construction...


  • Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Newcastle University Full time

    Salary:Research Assistant: £31,396 to £32,982 per annumResearch Associate: £33,966 per annumNewcastle University is a great place to work, with excellent benefits. We have a generous holiday package; plus the opportunity to buy more, great pension schemes and a number of health and wellbeing initiatives to support you.Closing Date: 15 November 2023The...


  • Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom NORTHUMBRIA UNIVERSITY Full time

    ABOUT THE ROLEJoining a dynamic, multi-disciplinary team, you will support the project Investigators to drive forward research activities for the "Sustainable Style for Clean Growth: Innovating Textile Production through Engineering Biology" project. We're in search of two dedicated, motivated, and innovative researchers to join the Living Construction...


  • Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom NORTHUMBRIA UNIVERSITY Full time

    ABOUT THE ROLEJoining a dynamic, multi-disciplinary team, you will support the project Investigators to drive forward research activities for the "Sustainable Style for Clean Growth: Innovating Textile Production through Engineering Biology" project. We're in search of two dedicated, motivated, and innovative researchers to join the Living Construction...