Document Quality Associate

Responsibilities Have a good knowledge of, and perform regulated studies to the appropriate GLP/GCP standards and latest regulatory guidelines Be familiar with, and work in accordance with, SOPs and Study Documents Complete all paperwork in compliance with good record keeping principals; correctly and on time with GLP/GCP QC check the reports to a consistent and high standard including reviewing of study files against standard check lists Be able to accurately communicate findings identified during the QC check Make suggestions as to how processes can be improved, and efficiency maximised Take an interest in your own personal development, seek out training, and look for opportunities to grow Embrace Resolian values and be respectful to colleagues Be flexible; realise that timelines, priorities and requirements will change regularly and respond to these challenges positively Take responsibility for knowing what needs to be done each day, and doing it promptly Familiarise yourself with, and work to, the Health and Safety Policy relevant to your role, paying particular attention to COSHH in the lab Complete any Mandatory Training appropriate for your role Have a good knowledge of QC checking reports including documents, data and data tables produced within the IA and LCMS Bioanalysis departments Understand how to QC check sample management documentation Use Watson LIMS and ResoLIMS to QC check report text, tables and figures Focus on quality and attention to detail with an ability to perform QC check in a meticulous manner Communicate with Report Writers and SD/PI/APMs to provide updates on QC check progress. Update SharePoint and the Team forum appropriately Liaise with the relevant SD/PI/APM and/or Report Writer for any matters that require further discussion Work with QA to discuss audit findings and develop a clearer understanding of what is required, ultimately leading to enhanced efficiency and effectiveness Communicate workload to the line manager and make sure that the day to day workload is manageable Work with the QC team to provide cover for other team members as required Look for opportunities outside of your core role. Contribute and participate without affecting your day to day responsibilities Skills, Education & Qualifications Solid knowledge of reviewing QC documents, data and data tables Solid knowledge of GLP/ GCP regulations Strong Watson/ LIMS experience