Document Quality Associate (must be onsite daily)

Must be able to commute to the Fordham office on a daily basis. Relocation is not available.

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

…