Document Quality Associate in Fordham

Document Quality Associate role at Resolian UK.

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 principles; correctly and on time with GLP/GCP.

QC check the reports to a consistent and high standard including reviewing study files against standard check‐lists.

Accurately communicate findings identified during QC check.

Make suggestions to improve processes and maximise efficiency.

Take an interest in personal development, seek training, and look for growth opportunities.

Embrace Resolian values and be respectful to colleagues.

Be flexible; respond positively to changing priorities and timelines.

Take responsibility for daily tasks and complete them promptly.

Familiarise yourself with, and adhere to, the Health and Safety policy, paying particular attention to COSHH in the lab.

Complete any mandatory training appropriate for role.

Have a good knowledge of QC checking reports (documents, data, tables) produced within 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 detail with meticulous QC checking.

Communicate with Report Writers and SD/PI/APMs to provide updates on QC progress and update SharePoint and the Team forum appropriately.

Liaise with relevant SD/PI/APM and/or Report Writer for further discussion.

Work with QA to discuss audit findings and develop clarity on requirements, leading to enhanced efficiency.

Communicate workload to line manager and ensure manageable daily workload.

Work with the QC team to provide coverage for others as needed.

Look for opportunities outside of core role and contribute without affecting day‐to‐day responsibilities.

Qualifications

Solid knowledge of reviewing QC documents, data and data tables.

Solid knowledge of GLP/GCP regulations.

Strong Watson/LIMS experience.

Hiring DetailsEntry level | Full‐time | Quality Assurance

#J-18808-Ljbffr