Arcinova, A Quotient Sciences Company, is dedicated to providing innovative contract research, development, and manufacturing services. We offer a comprehensive range of integrated specialist services for early stage drug development, underpinned by strong industry knowledge and scientific expertise. Our mission is to bring science, innovation, and collaboration together to overcome the barriers in drug development. We empower emerging biotechs and large pharma alike to bring life-changing therapies to patients faster, through an efficient, effective approach focused on quality, science, and innovation. Our vision is to advance progress through science, delivering solutions that make a measurable difference. We look ahead with purpose, driven to shape a smarter, more resilient future for all. Summary of Job Purpose To provide QA support to operations functions at the QS Alnwick site and assist in maintaining the site Quality Management System (QMS), ensuring compliance with GxP guidelines and regulatory requirements. Key Responsibilities Prepare, review and approve quality documents including batch manufacturing records and study reports. Act as QA representative for Quality Events and serve as RCA coach. Provide support for the use of the electronic Quality Management System (eQMS). Assist in the preparation and review of Quality Agreements. Participate in the Supplier Qualification programme. Assist in the conduct of site audits, including: Facility-based audits GxP process-based audits Study data and report reviews Support customer audits and regulatory inspections, including completion of questionnaires, coordination of responses and follow-up of corrective actions. Ensure compliance with GxP guidelines and regulations as required by the role. Qualifications & Experience Educated to degree level (or equivalent) in a relevant scientific discipline. 1–2 years’ experience in a GMP Quality role (QA/QC). Key Skills Strong interpersonal and communication skills, both written and oral. Self-motivated with the ability to work independently and as part of a team. Excellent attention to detail and organisational skills. High level of personal integrity and commitment. Flexible approach to new work challenges. 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.