Senior Validation QA Associate
2 weeks ago
Quotient Sciences: Molecule to Cure. Fast.
We accelerate drug development by integrating formulation development, clinical testing, data sciences, and manufacturing into one seamless process. Our proprietary platform, Translational Pharmaceutics, shortens timelines by 9–12 months on average.
Arcinova, our specialist arm in Reading and Alnwick, UK, delivers end-to-end drug substance and early drug product services, including bioanalysis and radiolabeling—streamlining early development from candidate selection to proof of concept.
Why join us?
Because every day counts when bringing new medicines to patients. Our 1,000+ experts across the US, UK, and beyond are united by science, agility, and a culture that turns ideas into impact—fast.
The Role
Quotient Sciences is seeking a Senior Validation QA Associate to join our Quality Assurance team. This role ensures compliance with GXP guidelines and regulatory expectations for computer system and equipment validation and qualification. You will lead validation projects, maintain documentation, and support continuous improvement initiatives across our Nottingham site.
This is a hybrid role with the expectation of a minimum of 3 days onsite each week.
Key Responsibilities
- Lead multi-functional teams on computer system and equipment validation and qualification, including change management of validated systems.
- Ensure validation processes are effective and compliant with regulatory requirements.
- Author, review, and approve validation documentation (protocols, reports, incident reports).
- Maintain validation records (paper and electronic) and conduct periodic reviews of systems and spreadsheets.
- Provide technical validation support and share expertise across the organisation.
- Support audits and inspections, presenting validation evidence as required.
- Drive continuous improvement to reduce risk and enhance efficiency.
Qualifications & Experience
- Life Science degree (or equivalent).
- Minimum 2 years' experience in Computer System Validation within a GCP or GMP environment.
- Strong communication skills with the ability to collaborate across teams and organisational levels.
Job Demands
- High concentration and attention to detail.
- Ability to meet strict deadlines and manage multiple tasks simultaneously.
- Occasional work outside normal hours to meet client demands.
- Compliance with safety procedures in a regulated environment.
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.
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