Document Quality Associate

Job Description Responsibilities Have a good knowledge of, and perform regulated studies to the appropriate GLP/GCP standards and latest regulatory guidelinesBe familiar with, and work in accordance with, SOPs and Study DocumentsComplete all paperwork in compliance with good record keeping principals; correctly and on time with GLP/GCPQC check the reports to a consistent and high standard including reviewing of study files against standard check listsBe able to accurately communicate findings identified during the QC checkMake suggestions as to how processes can be improved, and efficiency maximisedTake an interest in your own personal development, seek out training, and look for opportunities to growEmbrace Resolian values and be respectful to colleaguesBe flexible; realise that timelines, priorities and requirements will change regularly and respond to these challenges positivelyTake responsibility for knowing what needs to be done each day, and doing it promptlyFamiliarise yourself with, and work to, the Health and Safety Policy relevant to your role, paying particular attention to COSHH in the labComplete any Mandatory Training appropriate for your roleHave a good knowledge of QC checking reports including documents, data and data tables produced within the IA and LCMS Bioanalysis departmentsUnderstand how to QC check sample management documentationUse Watson LIMS and ResoLIMS to QC check report text, tables and figuresFocus on quality and attention to detail with an ability to perform QC check in a meticulous mannerCommunicate with Report Writers and SD/PI/APMs to provide updates on QC check progress. Update SharePoint and the Team forum appropriatelyLiaise with the relevant SD/PI/APM and/or Report Writer for any matters that require further discussionWork with QA to discuss audit findings and develop a clearer understanding of what is required, ultimately leading to enhanced efficiency and effectivenessCommunicate workload to the line manager and make sure that the day to day workload is manageableWork with the QC team to provide cover for other team members as requiredLook for opportunities outside of your core role. Contribute and participate without affecting your day to day responsibilitiesSkills, Education & Qualifications Solid knowledge of reviewing QC documents, data and data tablesSolid knowledge of GLP/ GCP regulations Strong Watson/ LIMS experience

Created: 2025-12-28