Site Archivist and Quality Support
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.
To act as the Site Archivist and Site Lead Administrator for the electronic Quality Management System. To provide support to the operational QA team with respect to audit planning, quality metrics & KPIs, client audits/regulatory inspections.
Main tasks and responsibilities include
- Maintain the archive and associated systems in compliance with appropriate GxP regulations, acting as the Site Archivist.
- Co-ordinate and administer records management and quality document system including record keeping and distribution of materials. Assist Operational Departments with their own records management system, where required.
- Act as Site Lead Administrator for the electronic Quality Management System. Work with Super Users to ensure that the system is implemented consistently across the site.
- Participate in and provide support for internal audits, Client audits and Regulatory inspections.
- Provide support to the operational QA team with respect to the planning of internal audits and hosting of client audits and regulatory inspections.
- Generate periodic reports on quality metrics and KPIs.
- Ensures work is conducted in compliance with relevant regulatory requirements, internal policies/procedures and client requirements where appropriate[variable].
- Works with due regard to health & safety of self & others.
- Works flexibly across the site to meet business needs.
The successful candidate will have a good understanding of GxP regulations, specifically the principles of archiving and quality document management.
Will be able to demonstrate good interpersonal and communication skills, both written and oral and have the ability to work independently.
They will have a high level of personal integrity and commitment, with a flexible approach to new work challenges.
Other skills and and experience required
- Excellent attention to detail.
- Able to work well as part of a team.
- Degree level (or equivalent) in a relevant scientific discipline.
- Previous experience of working in a GxP environment is desirable.
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 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 & inclusion 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.