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Quotient Sciences

QC Equipment Validation Owner

Alnwick
Posted about 1 month ago
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QC Equipment Validation Owner

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.

The Role

We are seeking an experienced QC Equipment Validation Specialist to join our Analytical Quality Control team in Alnwick. This is an exciting opportunity to play a key role in the installation, validation, and lifecycle management of analytical equipment within a regulated environment.

You will ensure QC equipment remains compliant with regulatory expectations throughout the validation and equipment lifecycle, liaising closely with Validation and Metrology teams. You will also support QMS activities related to equipment, including Data Integrity Assessments and deviation investigations.

In addition, you will contribute to the development of equipment training modules alongside the Analytical Trainer and support user training as required. Acting as a Super User for key QC systems (e.g. Chromeleon), you will play an important role in supporting system performance, troubleshooting, and continuous improvement across the QC function.

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Main Tasks And Responsibilities

Work with the Validation and Metrology teams to move equipment promptly through the validation process and into use Decommissioning of legacy equipment in line with company processes Prepare training modules for new equipment, and deliver new-user training to support handover of new equipment to the relevant analytical department Act as a Super User for relevant QC software systems (eg Chromeleon, ScheduleIT) Support Quality Events and other QMS activities related to equipment (eg Risk Assessments, Change Controls, Deviations, Periodic Validation Reviews) Assist QC Support Team with calibration and environmental mapping activities Act as a ‘go to’ person for assistance in equipment troubleshooting activities Work with due regard to health and safety of self, as well as ensuring others are working to the requisite standards Work flexibly across the site to meet business needs.

About You

BSc (Hons) or equivalent in a relevant scientific discipline Strong experience across the full equipment validation lifecycle (from installation through to retirement) Proven track record of validating analytical equipment in a regulated environment Highly competent with laboratory instrumentation and software systems Ability to critically assess data and adapt to changing priorities Experience supporting or delivering training is advantageous Strong communication skills, both written and verbal

Eligibility to Work in the UK

Please note that this position is not eligible for sponsorship under the UK points-based immigration system. If you require sponsorship, we will be unable to progress your application or make an offer of employment.

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As this is a permanent role, we are also unable to accept applications from candidates on a Graduate Visa.

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.

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Skills

QC Equipment Validation
Analytical Quality Control
Regulatory Compliance
Data Integrity Assessments
Troubleshooting
Laboratory Instrumentation
Software Systems
Training Delivery
Communication Skills
Risk Assessments
Change Controls
Calibration
Environmental Mapping
Continuous Improvement
Health and Safety

Location

Alnwick, England, United Kingdom

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