QA Officer - Validation
Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients.
As a growing and successful business, we employ more than 1,100 talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA.
Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it. People join Quotient Sciences because we are a respected member of the drug development community, driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.
An opportunity has arisen for a QC Auditor to join the Bioanalysis Team. The role will be to carry out internal QC Audits of Bioanalysis in accordance with regulatory and company procedures. Complying and adhering to GxP guidelines and regulations as required of this role.
- QC audit of ICP-MS, GC-MS and LC-MS bioanalytical assay validation, analysis and data transfer in compliance with relevant regulatory requirements, internal policies/procedures and client requirements where appropriate.
- Prepare and audit study-specific documentation (i.e. protocol/SAO/reports) for study directors and clients in a timely manner
- Assist study directors with delivery of their duties, including client contact.
- Prepare and update documentation (policies, procedures, guidance’s and methods) that are critical to operation of bioanalysis
- Participate in client and regulatory audits.
- Support HOD with business management, including planning, revenue recognition and development of bioanalytical proposals
- Ensures work is conducted in compliance with relevant regulatory requirements, internal policies/procedures and client requirements where appropriate.
- Works with due regard to health & safety of self & others
- Works flexibly across the site to meet business needs
The successful candidate will have:
- BSc or equivalent in relevant scientific subject
In return, you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.
Our commitment to Diversity & Inclusion
Quotient Sciences business are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient family by remaining committed to the development of our culture, equality, mindset, diversity & inclusions in the workplace.
As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today. All applicants welcome.