QA Officer Alnwick, England
Job description
Company Overview
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.
The Role
An opportunity has arisen for a QA Officer to provide QA support operations functions at the Alnwick facility. Assisting in the maintenance of the site GxP (GMP, GLP and GCP) quality management system.
Key Tasks:
Preparation, review and approval of quality documents including batch manufacturing and synthesis records
Act as QA representative in Quality Events and RCA coach
Provide support for use of the eQMS
Assist in the preparation and review of Quality Agreements
Participate in the Supplier Qualification program
Assist in the conduct of site audits including:
Facility based audits, GxP process-based audits, GLP/GCP reports and data
Provide support for customer audits and regulatory inspections, including completion of questionnaires, coordination of responses and follow up of corrective actions
Prepare and deliver GxP training
To comply & adhere to GxP guidelines and regulations as required of this role
The Candidate
Educated to degree level (or equivalent) in a relevant scientific discipline
Previous experience of working in a GxP environment
Experience in a QC or QA role would be advantageous
Key Skills;
Able to demonstrate good interpersonal and communication skills, both written and oral, and must be self-motivated. The ability to work independently, as well as being part of a team, is a key aspect of the role, as is attention to detail. A high level of personal integrity and commitment is essential, as is a flexible approach to new work challenges.
Company benefits:
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.
