Quality Assurance 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 help biotech and pharma customers save precious time and money in getting drugs to patients.

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 that’s focused on innovation and are driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.

Summary of job purpose:

• Ensure that Quotient Sciences remains current and compliant with regulatory expectations on equipment and computerised system validation.
• Support Alnwick Operations teams to ensure validation projects are completed in line with Quotient procedures and regulatory requirements.
• To comply & adhere to GXP guidelines and regulations as required of this role.
• Ensure that validation procedures are harmonised with global Quotient requirements.
• Responsible for ensuring compliance through the Quality framework and follow procedures that govern the work performed in this role.

Main tasks and responsibilities:

• Authoring, reviewing and approving facilities, utilities, equipment, computerized system, and spreadsheet validation documents.
• Authoring, reviewing, and approving incidents reporting as part of a validation project.
• Providing technical validation support to operational colleagues.
• Supporting ongoing change management of validated systems.
• Supporting the maintenance of the site Validation Master Plan.
• Maintenance of validation documentation (paper-based and electronic).
• Conducting periodic reviews of validated systems.
• Maintain up to date knowledge of regulations & industry best practice relating to validation.
• Assist with internal & customer audits and regulatory inspections where required.
• Perform other duties as reasonably assigned.

Qualifications and experience required for competent performance:

• A Life Science degree and a minimum of 2 years validation experience relating to facilities, utilities, equipment & computerised systems within a GxP environment (Good Laboratory Practice (GLP), Good Clinical Practice (GCP) or Good Manufacturing Practice (GMP)).
• Relevant quality assurance or IT experience will also be considered.
• Excellent communication skills including the ability to effectively communicate across organisational levels and functions.
• Competent in the use of Microsoft Office packages including Word, Excel, etc.

Application Requirements:
When applying for a position with Quotient Sciences, 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 organisation. As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today.

Specifically, we will not discriminate on the basis of race, colour, 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.

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