QA Officer (Operations)
QA Officer (Operations)
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.
Quotient Sciences are expanding rapidly, with a clear commitment to drug substance development and manufacture and have recently announced a $8m investment in a new kilo lab facility which will be fully operational in 2022. We are currently recruiting for a QA Officer to work within the QA team at our Alnwick facility.
The key tasks and responsibilities of the position are:
- Help maintain the GxP (ie. GLP, GCP & GMP) quality management system, including:
- The conduct of a program of internal audits including process, facility, batch records, reports & data
- Preparation and review and approval of quality documents
- Preparation and review of Quality Agreements
- Act as QA representative in Quality Events
- Participation in the Supplier Qualification program
- Provide support for client audits and regulatory inspections, including coordination of responses and follow up of corrective actions
- Preparation and delivery of GxP training
- Provide QA support and input to ensure facilities, utilities, equipment and computer systems are appropriately validated/qualified
- Provide help and support to other teams as requested by management
The successful candidate will have:
- Educated to degree level (or equivalent) in a relevant scientific discipline
- Previous experience in a similar role or experience/awareness of GxP in a pharmaceutical environment is preferred.
Other skills and experience required:
- Good written/oral communication skills
- A high level of personal integrity and commitment
- Flexible approach to new work challenges
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.