QC Specialist

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

• Supports Clinical Manager to ensure data integrity during study set up and data collection  
• Timely reviews source data collected for data integrity and compliance with Good Documentation Practices and relevant SOPs 
• Reconciles source data collected on paper with eSource comments and entries 
• Works with the clinic and project management departments to ensure that qc and query resolution timelines are being met 
• Works with Clinical Manager to implement measures to uphold   data integrity 
• Complies & adheres to GCP guidelines and regulations as required of this role. 
• Ensures study data is collected to a high quality in accordance with Good Clinical Practice (GCP) standards. 
• Ensures subject safety at all times 

Main Tasks and Responsibilities 

• Serves as support for Clinical Manager to ensure studies are set up for successful and high-quality data collection 
• Understands clinical protocols and requirements for data collection 
• Performs real-time QC checks on critical data as assigned by Clinical Manager 
• Ensures proper QC checks are performed on all clinical data for data integrity, particularly looking for incomplete or implausible data 
• Resolves queries as per scope and coordinates resolution of queries requiring other clinical parties 
• Ensures queries are addressed and resolved by the appropriate parties; assists as needed 
• Identifies discrepancies in source documentation and works with clinical staff for corrections and/or explanations. 
• Promptly reports any evidence or suspicion of fraudulent data collection or documentation  
• Evaluates query responses in eSource. May reissue query as necessary and re-train staff as appropriate  
• Reports/records protocol deviations encountered during review of clinical data 
• Ensures paper sources are transcribed appropriately and timely into the eSource capture system  
• Assists with QC of study activity schedules against  the eSource build during study start up 
• Prepares the initial template for lab tracking and ensures lab tracking is up to date. 
• Works collaboratively with the Clinical Leads during study start up to plans for high quality data collection for all studies  
• Works with the Project Management team to ensure the timelines are being met for QC and query resolution 
• Assists with retrospective review of clinical data, e.g. in quality deviation investigations, upcoming audits, etc. 
• Assists with activities to support validation of clinical systems
• Acts as a recorder for clinical activities in eSource as required 
• Performs clinical activities according to scope of practice  

The Candidate

• Minimum 2 years’  relevant experience in a clinical environment or equivalent experience in another role 
• Proficient in the use of Microsoft Office packages including Word, Excel...etc. 
• Attention to detail and organizational skills required  
• Able to assume increasing levels of responsibility and perform effectively 
• Able to plan, coordinate, organize, and prioritize to meet deadlines 
• Able to interact successfully with team members and study participants 
• Self-directed - able to perform with minimal supervision 
• Able to read and understand protocols 

Job Demands 

The job may involve the following: 

• Very high concentration of work 
• Strict and tight deadlines 
• Having to juggle a range of tasks/issues simultaneously 
• Working outside normal business hours 

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.

Our Approach to AI in Recruitment

At Quotient Sciences, we use technology, including AI-enabled tools, to support parts of our recruitment process and help create an efficient, consistent, and inclusive candidate experience. Any use of AI is subject to human oversight, and hiring decisions are made by people, not technology.

While we embrace innovation, our recruitment process remains deeply human. Candidates who progress through our recruitment process are supported by a dedicated recruitment contact, and many of our selection processes include in-person interviews. We believe the best hiring decisions come from real conversations, giving candidates the opportunity to meet future colleagues, experience our culture and showcase their strengths beyond their application.

We recognize that candidates may choose to use AI tools when preparing applications. We encourage the responsible use of technology to support research, preparation, and drafting. However, applications should reflect your own skills, experiences, and perspectives. Throughout the recruitment process, we assess authenticity, critical thinking, technical capability, and the unique contribution you can bring to Quotient Sciences. Content generated entirely by AI may not provide an accurate representation of your suitability for the role.