Document Quality Associate (must be onsite daily) Entry Level Position

Resolian; Fordham; On-site; GBP 30,000 - 42,000; Full time

Job summary

Resolian is seeking a detail-oriented QC Analyst to ensure regulatory compliance and high-quality outputs. You will perform regulated studies to GLP/GCP standards, review SOPs, and maintain thorough documentation. The role emphasizes meticulous QC checks and collaboration with Report Writers and QA teams.

You will work with Watson LIMS and ResoLIMS to QC text, tables and figures, while supporting process improvements and training opportunities as part of your professional development.

Qualifications

• Knowledge of reviewing QC documents, data and data tables.
• Familiar with SOPs and study documents.
• Adheres to GLP/GCP guidelines and latest regulatory standards.
• Maintains good record-keeping practices and on-time paperwork.

Responsibilities

• Perform regulated studies to GLP/GCP standards and latest guidelines.
• QC check reports to high standard, review study files against checklists.
• Communicate findings from QC checks accurately to stakeholders.
• Suggest process improvements to increase efficiency and quality.
• Maintain health and safety awareness, COSHH compliance in the lab.

Skills

QC knowledge

Documentation review

Attention to detail

Communication

Education

BSc Life Sciences

Tools

Watson LIMS

ResoLIMS

Job description

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