As a Quality Document Associate, you'll play a vital role in ensuring the accuracy, integrity and quality of bioanalytical studies that support critical scientific and clinical research. Working within a regulated GLP/GCP environment, you'll review study documentation, reports, data tables and laboratory records to ensure they meet the highest standards of compliance and scientific excellence.
What will you be doing?
- 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
- Use Watson LIMS and ResoLIMS to QC check report text, tables and figures
- 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 Project Managers 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
The role requires someone to be flexible in their approach, taking into consideration that timelines, priorities and requirements can regularly change. We are always looking for ways to improve our internal processes, so if you are a problem-solver, you'll enjoy this role.
Who we're looking for
We are looking for someone with a good knowledge of regulatory guidelines and expectations including GLP and GCP. You will be familiar with, and be able to work in accordance with SOPs and study documents.
This is an ideal opportunity for someone who enjoys problem-solving, takes pride in delivering high quality outcomes and is keen to expand their expertise within a collaborative team.
You'll also have:
- Experience in reviewing or auditing documents, data and data tables
- Knowledge of GLP, GCP and other regulatory guidance and expectations
- Excellent attention to detail skills
- Strong communication skills and the ability to concisely provide information to stakeholders
- Experience with Watson/ LIMS would be an advantage in this role.
