Jobs
>
Cambridge

    Document Controller - Cambridge, United Kingdom - LEX Diagnostics

    LEX Diagnostics
    LEX Diagnostics Cambridge, United Kingdom

    3 weeks ago

    Default job background
    Description
    LEX Diagnostics are recruiting for an organised Document Controller to join the team. In this role, you will be responsible for providing technical documentation guidance for FDA submissions, reviews, and inspections related to LEX Diagnostics Products.

    LEX Diagnostics is an ambitious, well-funded point-of-care diagnostics business. We believe that fast, accessible molecular diagnostics will have a fundamental impact on how infectious diseases are managed at point of care and beyond. Our technology is uniquely able to address this challenge and we are commercialising it with partners who share our ambition. You can read more about LEX here.

    As someone with a background in molecular biology and previous experience working on FDA approvals, you'll easily collaborate with the verification and validation team to ensure that the regulated documentation is in place to support with FDA approvals. You will receive support from the Quality Systems Manager and play an integral role as a valued member of the LEX Diagnostics team.

    What you will be doing:
    • Manage the Quality and Regulatory documentation workflows for the LEX Product portfolio and adhere to ISO13485 requirements.
    • Coordinate and facilitate documentation reviews and approvals involving the relevant people
    • Assess the progress and effectiveness of the documentation control system, addressing any errors or discrepancies found.
    • Generate and manage product technical documentation such as Design History Files (DHF), Device Master Records (DMR), Risk Management Files (RMF), and Device Master Files (DMF) in accordance with procedures.
    • Identify and suggest enhancements to document control systems, offering continuous support and training to both new and existing LEX colleagues
    • Assist in developing and implementing document templates for Verification and Validation (V&V) activities

    Requirements

    Previous skills and experience that would be useful to be successful in this role:
    • Confident at using electronic Quality Management Systems
    • Strong communication skills and able to work in a multidisciplinary team.
    • Logical approach to constructing documentation with great attention to detail
    • Able to liaise with notification and regulatory bodies for product listing and certification processes
    • Any experience with Salesforce and in particular, Dot Compliance would be a benefit but is not essential.
    • Can solve documentation problems with tenacity and a sense of urgency

    Benefits

    LEX Diagnostics is part of TTP Group, an employee-owned business. It operates from green surroundings in Melbourn, less than 10 miles south of Cambridge. TTP Group takes a long-term approach to investment and has been at the forefront of point-of-care diagnostics for over 20 years. Drawing upon the expertise of its consultants in the Life Science sector, and the management experience of a company with a 30-year track record of developing breakthrough technology and creating ambitious tech businesses, TTP Group invested core IP and staff into LEX in 2020.

    Our Benefits Include

    • Annual profit-related bonus
    • Employer pension contribution of 12% of pensionable pay
    • Private medical insurance for employees and dependants
    • Free lunch and all-day refreshments
    • Life insurance worth 6 x salary
    • 25 days holiday with the option to carry over or bring forward 5 days
    • Enhanced maternity and paternity leave, with the option to return part-time for a year
    • Electric car leasing scheme
    • Cycle to work scheme
    • Public Transport Season ticket loan
    • A wide range of social clubs and activities including squash, Zumba, yoga, arts and crafts and even our own rock band
    • Local sports facilities and theatre discounts and memberships as well as our own onsite gym to use

    So, If you're passionate about document management and eager to make an impact in the field of diagnostics, we'd love to hear from you.

    Every application will receive a response.
  • Morgan Sindall Construction

    Document Controller

    2 weeks ago

    Morgan Sindall Construction Cambridge, United Kingdom

    **Document Controller** · **Location: Morgan Sindall Construction East - Cambridge** · We are looking for a highly organised and competent Document Controller to set up, manage and maintain project document control systems in line with the company, customer and project. · You wil ...

  • Bidwells LLP

    Document Controller

    2 weeks ago

    Bidwells LLP Cambridge, United Kingdom

    **Location: Cambridge** · **Contract Type: Permanent** · **Hours: Full Time** · **Salary: £30,000 - £40,000 per annum** · **Role overview**: · We are looking for a highly organised and competent Document Controller who enjoys working in a team to join our Compliance department he ...

  • Falcon Green

    Document Controller

    1 week ago

    Falcon Green Cambridge, United Kingdom

    Falcon Green is currently recruiting for a Document Controller to work with a privately-owned, award-winning Construction Company. The Document Controller will work across a groundbreaking £116M mixed-use development project based in Cambridge that is due to run well into 2025, w ...

  • AWC Staff Services Ltd

    Document Controller

    2 weeks ago

    AWC Staff Services Ltd Cambridge, United Kingdom

    Document Controller to cover Chelmsford and Cambridge initially · Contract to permanent · **Salary**: £30,000 - £35,000 negotiable depending on experience · As an experienced document controller who has worked on gas sites you will: · Be able to set up the document control system ...

  • Morgan Sindall Construction

    Document Controller

    3 weeks ago

    Morgan Sindall Construction Cambridge, United Kingdom

    **Document Controller** · **Location: Morgan Sindall Construction East - Cambridge** · We are looking for a highly organised and competent Document Controller to set up, manage and maintain project document control systems in line with the company, customer and project. · You wil ...

  • Kier Group

    Document Controller

    1 week ago

    Kier Group Cambridge, United Kingdom

    We're looking for a **Document Controller** to join Kier Construction in the Eastern and Midlands Region. · **Location**: Waterbeach, Cambridgeshire with additional travel to sites and offices · **Contract**: Permanent**, **full time. · **Responsibilities** · We are now recruitin ...

  • Lightcast Discovery

    Document Controller

    2 weeks ago

    Lightcast Discovery Cambridge, United Kingdom

    Our mission is to push the boundaries of complex cell analysis. Using the Lightcast platform we are working with major pharmaceutical companies and leading academic institutes. Together, using our next generation microfluidic platform, we are making advances towards new science, ...

  • Cityscape Recruitment

    Document Controller

    2 weeks ago

    Cityscape Recruitment Cambridge, United Kingdom

    Document Controller - 4 Projects · £38,000 - £42,000 + Benefits · City of London · About the Company: · Our client is part of an up-and-coming wave of companies that pride themselves on the quality of their work. They mainly work across residential and commercial projects up to £ ...

  • Bidwells

    Document Controller

    2 weeks ago

    Bidwells Trumpington, United Kingdom

    We are looking for a highly organised and competent Document Controller who enjoys working in a team to join our Compliance department here at Bidwells. You will set up, manage and maintain different document control systems, working with a variety of teams and individuals across ...

  • Morgan Sindall Construction

    Document Controller

    1 day ago

    Morgan Sindall Construction Cambridge, United Kingdom

    **Document Controller** · **Morgan Sindall Construction East - Cambridge** · We are looking for a highly organised and competent Document Controller to set up, manage and maintain project document control systems in line with the company, customer and project. · You will assist p ...

  • Cityscape Recruitment Ltd

    Document Controller

    1 week ago

    Cityscape Recruitment Ltd Cambridge, United Kingdom

    **About the company** · My client is a Civil Engineering Tier Two subcontractor who also act as a main contractor on various projects. They currently operate in 8 countries and have a turnover of £250M. They work primarily on major infrastructure projects providing groundworks an ...

  • British Antarctic Survey

    Aimp Document Controller

    2 weeks ago

    British Antarctic Survey Cambridge, United Kingdom

    **Contract Type** · Full Time · **Duration** · 4 Years · **Salary** · £31,931 - £34,709 Per Annum · **Benefits** · We offer **generous benefits** · **Team** · AIMP · **Location** · BAS Cambridge · **Closing Date** · Sunday, August 20, 2023 · **Job Profile** · *** · **Description* ...

  • Morgan Sindall Construction

    Document Controller

    2 weeks ago

    Morgan Sindall Construction Sawston, United Kingdom

    **Document Controller** · **Location: Morgan Sindall Construction East - Cambridge** · We are looking for a highly organised and competent Document Controller to set up, manage and maintain project document control systems in line with the company, customer and project. · You wil ...

  • Tiro Partners Limited

    Senior Document Controller

    1 week ago

    Tiro Partners Limited Cambridgeshire, United Kingdom

    Tiro have been given a number of vacancies to fill for a long term partners of ours, they are within the Power Generation sector and are now looking for a Senior Document Controller to join their team. · Document Control · Engineering function/office experience · Design drawings, ...

  • Fusion People Ltd

    Rail Document Controller

    2 days ago

    Fusion People Ltd Cambridge, United Kingdom

    **Fusion People** · **Role - Document Controller** · **Duration - 2 Years** · **Location - Cambridge** · **Day Rate - £250- £325 per day PAYE** · **Document Controller** · **Scope of Job** · *Meeting key Project Milestones, manage the throughput of Contract Document Deliverables ...

  • Morson Talent

    Document Controller

    2 weeks ago

    Morson Talent Swaffham, United Kingdom Full time

    Job Title: Document Controller · Location: Norfolk · Type: Contract (1 year) · Hours: 50 hours per week · Time: 7:30am-6:30pm · Administrates and maintains the technical · documentation at the construction site · Administrates and maintains the · documentation at site usi ...

  • Rullion

    Document Controller

    2 weeks ago

    Rullion Swaffham, United Kingdom Full time

    Rullion are looking to recruit for the following Role for one of our Global Leading Energy Clients : · Job Role : Document Controller · Location : Norfolk PE37 8DL · Start Date : ASAP · Duration : 12 months · Rate : £24 per hour (TBD) · Inside IR35 · Full time hours (10 per day ) ...

  • SMC Ltd.

    Document Control Officer

    3 weeks ago

    SMC Ltd. Waterbeach, United Kingdom

    We are seeking a Document Control Officer to support the Quality team and the wider business with the collation, transmission, filing and retrieval of documents and administrative responsibility for the Pharmaceutical Quality System. · **Key Responsibilities** · - Managing docume ...

  • Balfour Beatty

    Document Controller

    2 weeks ago

    Balfour Beatty Huntingdon, United Kingdom

    **About the role** · Balfour Beatty are currently looking for a **Document Controller** to join our UKCS Regional Buildings project site based in near **Huntingdon.** · **Roles Purpose**:To manage and control all site, project and CSUK or bid documentation on one or more bids to ...

  • Fawkes & Reece

    Document Controller

    1 week ago

    Fawkes & Reece Harlow, United Kingdom

    **Location**: Harlow · **Salary**: £35K- £40K per Year · **Contract**: Permanent · **Type**: Full Time · **Reference**: jsajfdf_ · **Posted**: August 16, 2023 · Document Controller Role · Location: Harlow, Essex · Permanent basis · **Salary**: Upto £40k · Site based, 40 hour wor ...