QC Coordinator I

Overview

Quotient Sciences: Molecule to Cure. Fast. Quotient Sciences is a leading drug development and manufacturing accelerator, helping biotech and pharma companies bring new medicines to patients faster. With over 35 years of experience and a track record of success, we provide Drug Product (CDMO) and Clinical (CRO) services across the entire development pathway, including formulation development, clinical pharmacology, clinical trials, and commercial product manufacturing. Our proprietary and disruptive platform – Translational Pharmaceutics – integrates Drug Product Manufacturing and Clinical Testing to eliminate silos in the drug development process. This in turn reduces costs, improves outcomes, and significantly accelerates drug development times.

Why Join Us Because every day counts when bringing new medicines to patients. Our 1,000+ experts across the US, UK, and beyond are united by science, agility, and a culture that turns ideas into impact—fast.

The Role

As a QC Coordinator I , you will provide quality control and administrative support to the Clinical and Statistical Programming group. You will play an important role in ensuring the accuracy, consistency and integrity of clinical and statistical programming outputs, helping to maintain compliance with regulatory and Good Clinical Practice (GCP) requirements. Working closely with Clinical and Statistical Programmers, you will support the review of study outputs, preparation of key study documentation and archiving activities, contributing to the successful delivery of clinical projects.

Key Responsibilities

• Perform quality control (QC) reviews of programming output, including tables, figures and listings (TFLs).
• Assist with the creation and maintenance of annotated Case Report Forms (aCRFs).
• Support the team with study documentation and archiving procedures.
• Ensure all activities are conducted in accordance with Standard Operating Procedures (SOPs), regulatory requirements and applicable guidance.
• Maintain accurate records and documentation to support study deliverables.
• Provide general administrative and operational support to the Clinical and Statistical Programming group.
• Undertake additional duties and responsibilities as required by the business.

What You\'ll Bring

• Exceptional attention to detail and a commitment to quality.
• Experience undertaking administrative tasks and/or conducting quality control reviews of data or documentation.
• Good working knowledge of Microsoft Office applications, particularly Word and Excel.
• Strong verbal and written communication skills.
• Ability to organise workload effectively and manage multiple priorities.
• A proactive and team-oriented approach to work.

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.

#J-18808-Ljbffr