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Salary Alba Bioscience Limited
At AliveDx, we empower diagnostic insights, transform patient care, and innovate for life. With over 30-years in in vitro diagnostics, we put the health of patients first by creating innovative solutions designed for faster diagnostic results. Alba, our blood bank reagents portfolio and MosaiQ®, one of the first multiplexing and multimodality automated testing platforms, are designed to make labs more efficient and clinical decision-making more effective. Our journey started as Alba Bioscience, and later, Quotient. Today, as AliveDx, we innovate for life.
DOCUMENT CONTROLLER
The Document Controller will be responsible for the printing, control and co-ordination of documentation relating to Production Operations which form part Batch Manufacturing Records (BMR). These are considered to form defined Quality Records and are required to be held for a specified retention period as part of AliveDx’s QMS.
The Document Controller will ensure that all documents for these purposes are issued when required by the responsible process owners and that these are reconciled to demonstrate secure chain of custody throughout use. They will be responsible for the maintenance of records and documents both on and off site and provide administrative support to the Quality Department as and when required.
The job holder will be supported through development and training to become a subject matter expert on local processes and documentation allowing them to contribute to internal and external audits on these processes. They will become the owner of documents and processes and ensure their continued suitability for stated purposes. Training of other staff members will also be required as part of this role.
The role is a full-time, permanent position working 37.5 hours per week. This is to be based in our ARC office near Edinburgh, EH26 0BF.
Your main responsibilities will include:
The generation of BMRs for various manufacturing teams.
Ensuring the correct documents to support manufacturing and test operations are available in correct format and version to the required schedule.
Establishing and maintaining document issue / reconciliation records.
Maintenance of document inventory on and off site.
QUALIFICATIONS & EXPERIENCE REQUIRED
Demonstrable knowledge and expertise of MS Word and Outlook.
Confident with other core IT packages (ie. MS Office).
Excellent literacy and good numeracy skills.
YOUR COMPETENCIES
An understanding of the requirements of documentation in a GMP environment.
Good communication and interpersonal skills.
Effective time management skills.
Able to self-motivate.
Good attention to detail.
Demonstrates a high level of administrative competence.
WHAT WE OFFER
A highly dynamic and growing environment.
An opportunity to live your passion for intrapreneurial mindset, where cultivating innovation and customer centricity are at the heart of everything we do.
A flexible working environment where applicable and a range of core and flexible benefits ranging from private medical cover, life assurance, additional annual leave, cycle to work, technology, experience days and access to marketplace discounts.
ADDITIONAL INFORMATION
Competitive salary on offer
AliveDx offer a range of core and flexible benefits ranging from private medical cover, life assurance, cycle to work, technology, and restaurant discounts.
Interested ? We look forward to receiving your application.
AliveDx is an equal opportunity employer and welcomes applications from all qualified individuals regardless of nationality, sex, disability, region/belief, sexual orientation or age. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on competences, performance and business needs.
