At a Glance
- Tasks: Ensure quality control of documents and data while adhering to regulatory standards.
- Company: Join a dynamic team at Resolian, committed to excellence and personal growth.
- Benefits: Gain hands-on experience in a supportive environment with opportunities for training.
- Other info: Onsite role with a focus on teamwork and continuous improvement.
- Why this job: Kickstart your career in quality control and make a real impact on research integrity.
- Qualifications: Attention to detail and a passion for quality assurance are essential.
The predicted salary is between 22050 - 26950 £ per year.
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 principles; correctly and on time with GLP/GCP.
- QC check the reports to a consistent and high standard including reviewing of study files against standard checklists.
- 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.
Document Quality Associate (must be onsite daily) Entry Level Position in Fordham employer: Resolian
Resolian in Fordham is an exceptional employer that prioritises employee development and fosters a collaborative work culture. With a focus on quality assurance and innovation in the pharmaceutical sector, employees benefit from hands-on experience with cutting-edge analytical techniques and opportunities for professional growth in a supportive environment.
We think you need these skills to ace Document Quality Associate (must be onsite daily) Entry Level Position in Fordham
Knowledge of GLP/GCP standards
Familiarity with SOPs and Study Documents
Good record keeping principles
QC checking reports
Attention to Detail
Effective Communication Skills
Problem-Solving Skills
