At a Glance
- Tasks: Support and maintain the GxP Quality Management System in a dynamic environment.
- Company: Join Arcinova, a leader in innovative drug development services.
- Benefits: Competitive salary, career growth, and a commitment to diversity and inclusion.
- Other info: Flexible work challenges and opportunities for personal development.
- Why this job: Make a real impact in quality assurance for life-changing therapies.
- Qualifications: Degree level education and experience in a GxP environment required.
The predicted salary is between 30000 - 40000 £ per year.
Arcinova, a Quotient Sciences Company, is dedicated to providing innovative contract research, development, and manufacturing services. We offer a comprehensive range of integrated specialist services for early stage drug development, underpinned by strong industry knowledge and scientific expertise. Our mission is to bring science, innovation, and collaboration together to overcome the barriers in drug development. We empower emerging biotechs and large pharma alike to bring life-changing therapies to patients faster, through an efficient, effective approach focused on quality, science, and innovation. Our vision is to advance progress through science, delivering solutions that make a measurable difference.
The Role
We are looking for a QA Officer (Operations) for an onsite opportunity in Alnwick. In this role, you will support and maintain the site's GxP (GMP, GLP, GCP) Quality Management System. This is an excellent opportunity for someone with experience in a regulated environment who is looking to further develop their career in Quality Assurance. You will play a vital role in ensuring ongoing compliance with GxP guidelines and regulations, supporting both site operations and audit readiness.
Main Responsibilities
- Support the maintenance of the site's GxP Quality Management System
- Conduct a programme of internal audits, including: Facility audits, GLP/GCP report and data audits
- Prepare, review, and approve quality documents
- Prepare and review Quality Agreements
- Participate in the Supplier Qualification programme
- Provide support for the eQMS (Veeva)
- Act as QA representative for quality events
- Support customer audits and regulatory inspections, including: Coordinating responses, Tracking corrective actions
- Prepare and deliver GxP training sessions
Skills and Experience Required
- Educated to degree level or equivalent
- Previous experience of working in a GxP environment
- This role will primarily support GCP/GLP quality assurance activities therefore previous analytical/QC experience would be highly advantageous
- Good interpersonal and communication skills, both written and oral
- Self‐motivated with the ability to work independently and as part of a team
- Strong attention to detail
- High level of personal integrity and commitment
- Flexible approach to new work challenges and changing priorities
Eligibility to Work in the UK
Please note that this position is not eligible for sponsorship under the UK points-based immigration system. If you require sponsorship, we will be unable to progress your application or make an offer of employment. As this is a permanent role, we are also unable to accept applications from candidates on a Graduate Visa.
Application Requirements
When applying for a position with Quotient Sciences to be able to work in our organization you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined.
Our Commitment to Diversity, Equity and Inclusion
Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organization. As a global employer, we recognize the value in having an organization that is a true reflection and representation of our society today.
Specifically we will not discriminate on the basis of race, color, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws. This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.
QA Officer (Operations) in Alnwick employer: Quotient Sciences
Arcinova, a Quotient Sciences Company, is an exceptional employer that fosters a collaborative and innovative work culture in Alnwick. With a strong commitment to employee growth, we provide comprehensive training and development opportunities within the dynamic field of Quality Assurance, ensuring our team members are equipped to make a meaningful impact in drug development. Our dedication to diversity, equity, and inclusion creates a welcoming environment where every individual can thrive and contribute to advancing science for a better future.
StudySmarter Expert Advice🤫
We think this is how you could land QA Officer (Operations) in Alnwick
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their mission and values, especially how they relate to quality assurance in drug development. This will help you tailor your answers and show you're genuinely interested.
✨Tip Number 3
Practice common interview questions, but also be ready for situational ones related to GxP compliance. Think of examples from your past experience that highlight your skills and how you’ve tackled challenges in a regulated environment.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who are proactive about their job search!
We think you need these skills to ace QA Officer (Operations) in Alnwick
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the QA Officer role. Highlight your experience in GxP environments and any relevant quality assurance skills. We want to see how your background aligns with our mission at Arcinova!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about quality assurance and how you can contribute to our innovative approach. Let us know what excites you about working with us!
Showcase Your Attention to Detail:In QA, attention to detail is key. When filling out your application, double-check for any typos or errors. We appreciate candidates who take the time to ensure their submissions are polished and professional.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, you’ll find all the info you need about the role and our company culture there!
How to prepare for a job interview at Quotient Sciences
✨Know Your GxP Guidelines
Make sure you brush up on your knowledge of GxP guidelines, especially GMP, GLP, and GCP. Being able to discuss these in detail will show that you understand the core of the QA Officer role and are ready to support compliance effectively.
✨Prepare for Internal Audits
Familiarise yourself with the internal audit process, including facility audits and data audits. Think of examples from your past experience where you've conducted or participated in audits, as this will demonstrate your hands-on knowledge and readiness for the role.
✨Showcase Your Communication Skills
Since good interpersonal and communication skills are crucial, prepare to discuss how you've effectively communicated quality issues or training sessions in previous roles. Be ready to provide specific examples that highlight your ability to convey complex information clearly.
✨Emphasise Your Attention to Detail
In QA, attention to detail is key. Prepare to share instances where your meticulous nature has led to successful outcomes, whether it was catching a critical error or ensuring compliance with quality documents. This will help illustrate your fit for the position.
