QA Associate

A BIT ABOUT US…
At F-star, we are dedicated to developing next generation immunotherapies to transform the lives of patients with cancer. We develop mAb², a novel class of disruptive bispecific antibody-based therapies that have the potential to overcome tumor resistance and restore anti-cancer immunity and responsiveness.
We are committed to delivering life-changing treatments for the estimated 80% of patients with cancer who currently fail to have a durable response to immunotherapies.
Our wholly owned pipeline shows focused and potent immune activation, with a promising safety profile to date.
We’re an agile, international team with dual headquarters in Cambridge, UK and Cambridge, Massachusetts. We empower our teams to decide where and when they work to deliver our goals.

YOUR ROLE IN OUR TEAM:
We have a great opportunity for a QA Associate to join our busy QA department, ensuring that GLP, GMP and GCP QA activities are supported, managed, and administered in compliance with approved procedures.

YOUR KEY RESPONSIBILITIES WILL INCLUDE:
You’ll be working closely with QA Management to provide operational support in the company’s GXP’s and managing the day-to-day quality processes to ensure compliance with approved procedures.
Responsibilities will include;
• Management and administration of the vendor audit programme using external auditors to execute the audits
• Management and administration of internal and external deviation, CAPA, change and OOX processes
• Management of the DMS using Veeva software including superuser administration
• Supporting provision of GXP training and administration of training records
• Check of protocols and reports generate by operational teams
• Performance of regulatory intelligence searches on vendors
• Compilation of data and metrics for the management review process
• Provision of guidance in quality processes and supporting continual improvement activities

A BIT ABOUT YOU:
You’ll be a confident communicator with demonstrated ability to work with diverse teams. Whilst being comfortable collaborating with others both in person and in a virtual environment, being a proactive self-starter when working independently is a must. As a pragmatic, solution driven individual with a can-do attitude, you’ll thrive in an environment which gives you autonomy to get things done. You’ll be able to prioritise your workload and adapt quickly to change when needed, whilst remaining organised and detail orientated.

YOUR SKILLS, KNOWLEDGE AND EXPERIENCE:
Essential:
• Bachelor’s degree preferably in a biological science related discipline, or equivalent and relatable industry experience
• Good understanding of GXP’s requirements pertinent to F-star products
• Broad practical experience of operational QA processes
Desirable:
• QA experience within a biotechnology company
• Operational QA CSV experience

WHAT WE CAN OFFER TO YOU:
We get things done, we keep things simple, and we’re driven by the science. We’re ambitious so we work hard to create an environment where we can take smart risks. We want to be innovative so encourage debate and collaboration to challenge the usual way of doing things. We love our celebrations, socialising and perks, which make F-star a fun and diverse place to work. And most of all, everyone has the opportunity to make a difference.

Benefits:
• Pension (8% Employer contribution)
• Equity Incentives
• Private Medical Insurance and Health Cash Plan
• Life assurance
• 25 days paid holiday, plus the option to buy 5 days
• Travel insurance
• Enhanced Maternity, Paternity, Adoption pay
• Agile working opportunities

OTHER DETAILS:
Our Laboratories and office space are based on the Babraham Research Campus, South Cambridgeshire. This role will require some travel to our offices.

This is a full-time position working 37.5 hours per week. F-star is proud to fully embrace agile working which gives you options in how, where and when you get your work done, including flexible working hours and home working.

NEXT STEPS…
If you feel this role is right for you, we’d love to hear from you.
To apply, please visit our website: https://www.f-star.com/about/careers/ and upload your CV for us to view. Those that shine brightest will be contacted to discuss the role further, however, we aim to get back to everyone with a response either way.
We may choose to close the role sooner than the application closing date depending on volume of candidates and so we encourage early applications.
If, along the way, you experience any difficulties with applying via our website, please email HR@f-star.com.
We aspire to be a diverse and inclusive workplace and strongly encourage suitably qualified applicants from a wide range of backgrounds to apply.
As part of our compliance in relation to the General Data Protection Regulations 2018 (GDPR) you can find our ‘Candidate Privacy Notice’ on the careers section of website.

Application Instructions: 

NEXT STEPS…
If you feel this role is right for you, we’d love to hear from you.
To apply, please visit our website: https://www.f-star.com/about/careers/ and upload your CV to complete your application. Those that shine brightest will be contacted to discuss the role further, however, we aim to get back to everyone with a response either way.
We may choose to close the role sooner than the application closing date depending on volume of candidates and so we encourage early applications.
If, along the way, you experience any difficulties with applying via our website, please email HR@f-star.com.
We aspire to be a diverse and inclusive workplace and strongly encourage suitably qualified applicants from a wide range of backgrounds to apply.
As part of our compliance in relation to the General Data Protection Regulations 2018 (GDPR) you can find our ‘Candidate Privacy Notice’ on the careers section of website.

Application Closing Date: 
17 May 2022