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- Tasks: Oversee quality and compliance of clinical activities in global trials.
- Company: Join Bionow, an award-winning company driving innovation in life sciences.
- Benefits: Enjoy international travel opportunities and a competitive salary of £41,000.
- Why this job: Be part of a team advancing healthcare research with impactful technologies.
- Qualifications: Degree or equivalent experience in a relevant field; GCP knowledge required.
- Other info: Experience with In-Vitro Diagnostics or Medical Device Regulations is a plus.
The predicted salary is between 34000 - 48000 £ per year.
Title: QA Officer – Clinical
Location: Greater Manchester
Salary: £41,000
About the Role
SRG is recruiting for a QA Officer with GCP experience to join an innovative company whose technologies are integral to the advancement of life science and healthcare research worldwide.
Based at their site in Greater Manchester, you will oversee quality and compliance of clinical activities supporting the testing and registration of diagnostic tests across global trials. The role involves international travel to sites across Europe and the USA.
Key Responsibilities:
- Work with the Clinical Affairs team to ensure compliance during trial activities (e.g., closure of deviations, handling complaints).
- Represent Clinical QA in planned and ongoing clinical trials, including reviewing clinically relevant documentation.
- Support qualification and perform independent QA audits of clinical study sites.
- Participate in the internal audit program.
- Review Clinical Affairs SOPs.
What We\’re Looking For:
- A degree or similar qualification in a relevant subject or equivalent experience.
- Proven experience in a GCP environment with knowledge of relevant regulations, standards, guidelines, and best practices.
- Knowledge of In-Vitro Diagnostic or Medical Device Regulations is advantageous.
- Audit experience and familiarity with regulatory inspections are desirable.
- Willingness and ability to travel internationally (Europe and USA).
Bionow is an award-winning business development and services company serving the life science sector in Northern England. We support business growth, innovation, and competitiveness through specialist services, guidance, networking events, and membership benefits. We welcome inquiries from current and potential members.
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SRG - QA Specialist - Clinical employer: Bionow
Contact Detail:
Bionow Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land SRG - QA Specialist - Clinical
✨Tip Number 1
Familiarise yourself with Good Clinical Practice (GCP) guidelines and relevant regulations. This knowledge 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 life sciences sector, especially those who work in QA roles. Attend industry events or webinars to make connections that could lead to referrals or insider information about the role.
✨Tip Number 3
Prepare for potential travel requirements by researching the clinical trial sites in Europe and the USA. Understanding the local regulations and cultural nuances can give you an edge during discussions about international travel.
✨Tip Number 4
Showcase any audit experience you have during conversations with us. Being able to discuss specific examples of how you've handled audits or regulatory inspections can set you apart from other candidates.
We think you need these skills to ace SRG - QA Specialist - Clinical
Some tips for your application 🫡
Understand the Role: Read the job description thoroughly to understand the key responsibilities and qualifications required for the QA Officer position. Tailor your application to highlight relevant experiences that align with these requirements.
Highlight Relevant Experience: Emphasise your experience in a GCP environment and any knowledge of In-Vitro Diagnostic or Medical Device Regulations. Use specific examples from your past roles to demonstrate your expertise and how it relates to the responsibilities outlined in the job description.
Craft a Strong Cover Letter: Write a compelling cover letter that not only introduces yourself but also explains why you are a great fit for the role. Mention your willingness to travel internationally and your audit experience, as these are key aspects of the job.
Proofread Your Application: Before submitting your application, carefully proofread all documents for spelling and grammatical errors. A polished application reflects your attention to detail, which is crucial for a QA role.
How to prepare for a job interview at Bionow
✨Know Your GCP Inside Out
Make sure you have a solid understanding of Good Clinical Practice (GCP) guidelines. Be prepared to discuss how you've applied these principles in your previous roles, as this will demonstrate your expertise and suitability for the QA Officer position.
✨Familiarise Yourself with Relevant Regulations
Research the specific regulations and standards related to In-Vitro Diagnostics and Medical Devices. Showing that you are knowledgeable about these areas can set you apart from other candidates and highlight your commitment to compliance.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in real-world situations. Think of examples from your past experiences where you successfully handled deviations or complaints during clinical trials, and be ready to explain your thought process.
✨Highlight Your Audit Experience
If you have audit experience, be sure to discuss it during the interview. Share specific examples of audits you've conducted or participated in, and how those experiences have prepared you for the responsibilities of the QA Officer role.
