Data Compliance Scientist/IT

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Job Title: Data Compliance Scientist/IT

Department: Bioanalytical Science – Data Compliance

Contract Type: Permanent

Salary: Negotiable

Working Hours: 37.5 hours per week (Negotiable)

Overview

Alderley Analytical is fast growing Contract Research Organisation (CRO) based at the prestigious Alderley Park in the heart of Cheshire. We provide specialist bioanalytical services to support our clients with their discovery and regulatory drug development programmes. We provide services to support our clients with small & large molecule, peptide, oligonucleotide, protein and biomarker projects through their pre-clinical and clinical projects.

Our facility has a wealth of state-of-the-art UPLC-MS/MS instruments complimented by many other analytical technologies including ELISA and MSD. We are undergoing a large investment in new premises and new technology to improve the compliance and capacity of the laboratory and increasing the number of drug products we support.

Due to the ongoing success of Alderley Analytical, we are looking for a Data Compliance Scientist to join our team. This role requires a motivated and enthusiastic individual with experience of administrating software, full training can be provided to the right candidates.
As a Data Compliance Scientist, you will be primarily office-based, working in a small team where you will be responsible for the continued compliance of computerised systems to the appropriate regulatory standard. You will be responsible for specific systems (i.e software, spreadsheets) where you will maintain the compliance of these systems, support AA staff in the use of these systems, maintain up to date system documentation and help with managing and testing changes to the system. You will also support the team in the testing and implementation of new systems.

Within the role you will also be part of the IT Team helping provide day to day support throughout the business. This will include and not be limited to, desktop support, troubleshooting issues within the Windows environment and hardware support which will include new device setups. There is also opportunity to work on larger scale IT Projects with the Head of IT Services in the continued development of ICT to keep Alderley Analytical in line with all current technology available and to ensure security compliance.

Alderley Analytical will offer the successful candidate an interesting and fulfilling career along with an excellent renumeration package including a competitive salary, generous holidays, private healthcare and pension fund.
For the right candidates we can offer a rewarding career up the scientific, management or project management ladders and we always offer promotions internally where possible before advertising externally.

Key Responsibilities

  • Act as the System Administrator and expert user for AA systems.
  • Ensure software systems are maintained appropriately and that periodic updates and enhancements are implemented and evaluated through change control.
  • Attend and draft responses to QA following system audits.
  • Understand the principles of GLP and GCP and conduct all work in a manner that is compliant with the regulatory requirements.
  • Support users in the day to day use of the AA computer systems, this will include training.
  • Setup of new user devices and Microsoft 365 accounts
  • Perform troubleshooting and problem solving of system software, IT software and IT hardware errors.  
  • Be the first line of contact between AA and IT/hardware provider, communicating and managing changes that are required.
  • Perform validation testing and periodic testing of AA computer systems to the appropriate regulatory, computer system validation (CSV) guidelines and data integrity guidelines.
  • Backup system monitoring.
  • Deputy archivist
  • Author and review SOPs and system documents where required.
  • Work closely with key stakeholders to ensure AA computer systems meet their requirements and identify process improvements.
  • Contribute to the continuous improvement process by identifying opportunities in the workplace where improvements can be made.

Essential Requirements

  • Good ability to prioritise work and split time so able to work on multiple ongoing projects
  • Strong organisational and document keeping skills
  • Good working knowledge of Microsoft operating systems (Win 10 & 11)
  • Knowledge of Microsoft 365
  • A good communicator with strong interpersonal skills and a team player. 
  • Has a delivery focus with a good work ethic. 

Desirable Requirements (Not essential)

  • Experience of working within a GLP/GCP accredited facility.
  • Experience of being System Administrator of software
  • A degree in a life sciences or chemistry related subject.
  • Worked in a bioanalytical laboratory performing quantitative analysis.
  • Knowledge of Microsoft 365 SharePoint, server operating systems (Server 2019, 2022) and virtualization platforms (Hyper-V). 
  • Good computer literacy and competent in Microsoft office applications Outlook, Powerpoint, Word, Excel.
  • Knowledge of scientific software platforms such as Analyst, Masslynx, Watson LIMS, Softmax Pro, and ELn.

Benefits

  • Competitive Salary
  • Pension Scheme
  • Private Healthcare (Option to include Partner and Family)
  • Flexible Working
  • 25 days holiday plus bank holidays and additional length of service days, up to a maximum of 30 days (Plus your birthday off)
  • Generous sick pay
  • Free Parking
  • Varied role providing a variety of experience that will lead to career progression for the right candidates.

If you want a varied and exciting career with Alderley Analytical in this period of exciting growth and opportunity, please send your CV and a covering letter via email to:

Jennifer.ayres@alderleyanalytical.com

or via mail to:

Jennifer Ayres
Alderley Analytical Limited
Alderley Park
Macclesfield
Cheshire SK10 4TG

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