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- Tasks: Join our quality assurance team to ensure compliance in clinical trials.
- Company: A leading higher education institution focused on research excellence.
- Benefits: Enjoy a two-year fixed-term contract with competitive salary and professional development opportunities.
- Why this job: Make a real impact in clinical research while working with diverse teams in a dynamic environment.
- Qualifications: BSc in Science or equivalent experience; QA or compliance experience in regulated labs is essential.
- Other info: Training provided for Quality Management System procedures; ideal for those passionate about science and compliance.
The predicted salary is between 36000 - 60000 £ per year.
A Scientific Officer (Quality Assurance) is required for our higher education client to join their quality assurance team within their research centre to contribute to their compliance by assuring that their clinical trial activities comply with good clinical practice (GCP) regulations and guidelines for laboratories.
You will work alongside multidisciplinary laboratory and support teams and contribute to maintaining and assuring that their Quality Management System (QMS) and associated documents are fit for purpose, that non-conformances are addressed, all regulated documentation and associated records are up to date, and provide guidance in relevant regulations, standards, and procedures. You will have the opportunity to work closely with personnel at all levels of the organisation to assure their regulated GCP activities meet the required standards.
As the Scientific Officer you will possess experience in a quality assurance or compliance role within a GxP regulated laboratory with knowledge of GCP regulations, internal audits, non-conformance (or deviation) and CAPA management. Ideally you will have experience with LIMS and QPulse. You will possess BSc (or equivalent) in Science or a related subject or have equivalent relevant experience.
Duties include:
- Using a range of Quality Management System procedures (training provided) duties will include conducting document reviews on behalf of QA.
- Undertake project reviews and activation within the laboratory information management systems (LIMS).
- Conduct scheduled internal audits.
- Support the completion of non-conformances and the timely delivery of QA activities.
- Ensure all QA documentation is completed and up to date.
- Prioritising workload whilst keeping the Head of Quality Assurance informed with regards to developments in the progress of projects.
- Interact with specialist teams and groups on all matters of GCP (Good clinical practice) compliance.
Essential skills & experience required:
- BSc (or equivalent) in Science or related subject or equivalent relevant experience.
- Relevant QA or compliance experience working in a regulated academic research or industrial laboratory setting.
- Working to GxP standards.
- Experience of internal audits, non-conformances and CAPA management (Corrective and preventative actions).
- Track record of delivering high quality work within agreed deadlines.
Knowledge of:
- Familiar with basic computing software (MS Office).
- Knowledge of GCP (Good Clinical Practice), GLP (Good Laboratory Practice), or GCLP (Good Clinical Laboratory Practice) requirements.
- Knowledge of audit and non-conformance management.
- Knowledge of root cause analysis techniques.
Desirable would be any of the following:
- Experience with LIMS.
- Experience with Q-Pulse software or equivalent electronic QMS.
- Experience in training staff.
- Experience of working in a translational/clinical environment.
- Experience of working to GCP, GLP or GCLP standards.
Scientific Officer - Quality Assurance employer: Certes
Contact Detail:
Certes Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Scientific Officer - Quality Assurance
✨Tip Number 1
Familiarise yourself with GCP regulations and guidelines. Understanding these standards will not only help you in interviews but also demonstrate your commitment to quality assurance in clinical trials.
✨Tip Number 2
Network with professionals in the quality assurance field, especially those who work in GxP regulated environments. Attend relevant conferences or webinars to make connections that could lead to job opportunities.
✨Tip Number 3
Gain hands-on experience with LIMS and Q-Pulse software if you haven't already. Familiarity with these systems can set you apart from other candidates and show that you're ready to hit the ground running.
✨Tip Number 4
Prepare for potential interview questions by reviewing common scenarios related to non-conformance management and CAPA processes. Being able to discuss your approach to these situations will showcase your expertise.
We think you need these skills to ace Scientific Officer - Quality Assurance
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in quality assurance or compliance roles, particularly within GxP regulated laboratories. Emphasise your knowledge of GCP regulations and any specific software like LIMS or Q-Pulse.
Craft a Strong Cover Letter: In your cover letter, explain why you are passionate about quality assurance in clinical trials. Mention specific experiences that demonstrate your ability to manage non-conformances and conduct internal audits.
Highlight Relevant Skills: Clearly outline your skills related to audit management, root cause analysis, and your familiarity with Quality Management Systems. Use examples from past roles to illustrate your capabilities.
Proofread Your Application: Before submitting, carefully proofread your application for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial in quality assurance roles.
How to prepare for a job interview at Certes
✨Know Your GCP Regulations
Make sure you have a solid understanding of Good Clinical Practice (GCP) regulations. Be prepared to discuss how these guidelines apply to your previous work and how you ensure compliance in a laboratory setting.
✨Showcase Your QA Experience
Highlight your experience in quality assurance or compliance roles, especially within GxP regulated environments. Be ready to provide specific examples of internal audits, non-conformance management, and CAPA processes you've been involved in.
✨Familiarise Yourself with QMS Tools
If you have experience with Laboratory Information Management Systems (LIMS) or Q-Pulse, be sure to mention it. If not, do some research on these tools and be prepared to discuss how you would adapt to using them in the role.
✨Prepare for Team Interaction Scenarios
Since the role involves working with multidisciplinary teams, think of examples where you've successfully collaborated with others. Be ready to discuss how you communicate quality standards and ensure compliance across different departments.