At a Glance
- Tasks: Support quality assurance for innovative biotech manufacturing and analytical operations.
- Company: Vertex, a leading global biotechnology company focused on transformative medicines.
- Benefits: Hybrid work model, competitive pay, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on compliance and continuous improvement.
- Why this job: Join a mission-driven team making a real impact in healthcare innovation.
- Qualifications: Bachelor's in biotech/life sciences and experience in GMP quality assurance.
The predicted salary is between 56700 - 69300 £ per year.
- GMP Operational Quality Senior Specialist, 24-month contract
- Type of Role : Contract position, Inside IR35
- Department : Operational Area Quality
Looking for opportunities with purpose, impact and possibilities?
Our client, Vertex, is a global biotechnology company that invests in scientific innovation.
As they grow their pipeline at pace, they are strengthening their reputation for creating transformative medicines for people with serious diseases.
General Summary
This role is recognised as an expert internally in the principles and application of quality assurance and compliance.
The person will provide QA support for manufacturing operations, analytical laboratory operations and materials management for the external Cell & Genetic Therapeutic programs.
This role will review & support activities related to product disposition including review of batch data, batch records, deviations, in-process data, EM data, QC release testing and other quality systems documentation.
- Key Duties & Responsibilities
- Supports for quality oversight of Vertex Cell and Gene Therapy manufacturing operations across all phases of development and commercial, support of analytical laboratory, materials management, and facility/engineering groups.
- Responsible for GMP batch disposition activities including review and approval of batch records, deviations, in-process data, EM data, QC release testing, materials review board and other quality activities as applicable to determine acceptability of product disposition.
- Support QA execution of process and OOS investigations, and associated CAPAs.
- Responsible for approval of COAs and product labelling.
- Provide manufacturing support and guidance for GMP product quality impact assessments at the Contract Manufacturers.
- Support GMP release of incoming raw material and components.
- Participates and supports in compliance activities and help drive the closure of any observations by partnering with Vertex Compliance and Quality Assurance for CDMO and CTO activities.
- Responsible for identifying compliance risks and gaps for GMP processes.
- Record and maintain daily/monthly/quarterly batch record metrics and assists department with required Quality System data review metrics and reporting.
- Support Cell & Genetic Program and Quality projects including Quality system, protocol and test data review and manufacturing process/SOP improvements.
Required Experience
- Bachelor's degree in biotech/life sciences field.
- Demonstrated experience providing QA support and oversight of GMP manufacturing operation.
- Experience successfully leading event investigations, Root Cause Analysis and CAPA.
- Experience with network-based applications such as Oracle, Track Wise, Veeva.
- Understanding of regulatory environment including quality systems and compliance.
- Ability to evaluate quality matters and make decisions utilizing risk-based approach.
- Ability to facilitate cross-functional meetings/ projects and effectively communicate with business stakeholders.
- Critical Thinking and Problem-Solving skills.
Vertex is partnering with Talent Works to manage their international temporary job openings.
If you are successful in your application, you will be employed by Talent Works to work on a temporary assignment at Vertex.
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GMP Operational Quality Senior Specialist, 24-month contract employer: Vertex Pharmaceuticals
Vertex Pharmaceuticals is an exceptional employer that prioritises employee well-being and professional growth. With a flexible hybrid working model, our team enjoys a supportive work culture that fosters collaboration and innovation, while also providing ample opportunities for career advancement in the dynamic field of tax compliance.
StudySmarter Expert Advice🤫
We think this is how you could land GMP Operational Quality Senior Specialist, 24-month contract
✨Join Biotechnology Meetups
Get yourself into the loop by joining local biotech meetups or workshops. These events are perfect for making connections with professionals in the field and can often lead to temporary gigs through word-of-mouth. Plus, you'll get to hear about the latest trends and developments directly from the source.
✨Showcase Your Passion in Science
Consider starting a blog or social media channel to showcase your interest in biotechnology. Share the latest research, your insights, and even your projects. This will not only enhance your visibility in the community but also attract potential employers like Vertex Pharmaceuticals who might be scrolling through for talent.
✨Tap into University Resources
If you’re still in school or recently graduated, don’t forget to use your university’s career services. They often have exclusive connections with companies looking for temporary staff. Reach out to them for internship listings and networking opportunities tailored to the biotech sector.
✨Apply Directly on Our Website
When you spot that perfect temporary role at Vertex Pharmaceuticals, make sure to apply directly through our website. This way, you’ll be in the best position to get noticed quickly and can show your enthusiasm for the role while filling out the application.
We think you need these skills to ace GMP Operational Quality Senior Specialist, 24-month contract
Some tips for your application 🫡
Showcase Relevant Lab Skills:In the biotech world, your lab skills are paramount. Make sure your CV highlights specific techniques and equipment you’ve used, such as PCR, gel electrophoresis, or cell culture. This will give us a clear picture of what you can bring to Vertex Pharmaceuticals as a temporary teammate.
Highlight Your Research Experience:If you’ve worked on any research projects — whether during your studies or in previous positions — make sure to detail these in your application. Include the objective, your role, and what you achieved. This will help us see your potential and fit for the temporary position at Vertex Pharmaceuticals.
Keep It Concise and Relevant:Especially for a temporary role, we want to see a clear and focused application. Tailor your CV and cover letter to emphasise the qualifications and experiences that are most relevant to the biotech field and the specific role at Vertex Pharmaceuticals. This shows us you’re genuinely interested and capable.
Be Clear About Your Availability:Since it’s a temporary role, let us know right away when you’re available to start and how long you can commit. Include this in your cover letter — this kind of transparency saves us all time and helps us find the right fit quickly at Vertex Pharmaceuticals.
How to prepare for a job interview at Vertex Pharmaceuticals
✨Brush Up on Your Biotech Basics
Understanding the fundamental concepts in biotechnology is crucial. Be ready to discuss core topics like genetics, molecular biology, or bioinformatics, especially if you're asked technical questions. We suggest revisiting your coursework or recent projects to refresh your memory.
✨Demonstrate Your Adaptability
Since this is a temporary role, they’re likely looking for someone who can jump in and get up to speed quickly. Share experiences where you’ve adapted to new environments, tools, or teams in a short space of time. It shows you're ready to tackle the challenge head-on!
✨Emphasise Your Lab Experience
If you’ve got hands-on experience in lab settings, now’s the time to showcase it. Talk about specific techniques you’ve mastered, like PCR or chromatography, and any relevant safety protocols you’ve followed. These details help paint you as an effective team member from day one.
✨Be Prepared to Explain Your Passion
Hiring managers want to see your motivation, especially for a temporary position in a fast-paced field like biotechnology. Be ready to discuss what excites you about the industry, your career goals, and how this role at Vertex Pharmaceuticals aligns with them. It’s all about showing that you’re not just looking for a job, but a stepping stone in your biotech journey.
