Must be able to commute to the Fordham office on a regular basis.
Responsibilities
- Have a good knowledge of, and perform regulated studies to the appropriate GLP/GCP standards and latest regulatory guidelines
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Be familiar with, and work in accordance with, SOPs and Study Documents
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Complete all paperwork in compliance with good record keeping principals; correctly and on time with GLP/GCP
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QC check the reports to a consistent and high standard including reviewing of study files against standard check lists
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Be able to accurately communicate findings identified during the QC check
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Make suggestions as to how processes can be improved, and efficiency maximised
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Take an interest in your own personal development, seek out training, and look for opportunities to grow
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Embrace Resolian values and be respectful to colleagues
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Be flexible; realise that timelines, priorities and requirements will change regularly and respond to these challenges positively
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Take responsibility for knowing what needs to be done each day, and doing it promptly
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Familiarise yourself with, and work to, the Health and Safety Policy relevant to your role, paying particular attention to COSHH in the lab
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Complete any Mandatory Training appropriate for your role
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Have a good knowledge of QC checking reports including documents, data and data tables produced within the IA and LCMS Bioanalysis departments
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Understand how to QC check sample management documentation
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Use Watson LIMS and ResoLIMS to QC check report text, tables and figures
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Focus on quality and attention to detail with an ability to perform QC check in a meticulous manner
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Communicate with Report Writers and SD/PI/APMs to provide updates on QC check progress. Update SharePoint and the Team forum appropriately
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Liaise with the relevant SD/PI/APM and/or Report Writer for any matters that require further discussion
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Work with QA to discuss audit findings and develop a clearer understanding of what is required, ultimately leading to enhanced efficiency and effectiveness
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Communicate workload to the line manager and make sure that the day to day workload is manageable
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Work with the QC team to provide cover for other team members as required
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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
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Solid knowledge of GLP/ GCP regulations
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Strong Watson/ LIMS experience
