Analytical Operations Associate

at  Quotient Sciences

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

• To perform the review of analysis, documentation and raw data generated (including Empower and ELN) and recorded in compliance with GMP as per associated documentation.
• Author and review of analytical documentation.
• Involved in raw material release activities, external testing support and stability pulls and set down.
• Archiving of analytical documentations as required.

Qualifications and experience required for competent performance

• Minimum HND/HNC or equivalent experience in a laboratory focussed discipline.
• Minimum 3 years in Pharmaceutical, Analytical Chemistry.
• Experience of working to cGMP, reviewing of GMP documentations and understanding of the ALCOA+ principle
• General awareness and understanding of routine analytical techniques and data used within pharmaceutical industries.
• Very good interpersonal and communication skills.
• Very good attention to detail and good documentation writing
• Preferably some knowledge in the use of Waters Empower systems.

Main tasks and responsibilities

• Support activities for data verification, review of laboratory data including lab notebooks, ELN, raw data packages (including Waters Empower) and Excel spread sheets etc.
• Ensuring all work being reviewed has been generated and recorded in compliance with GMP and as per SOP, test method, protocols or any relevant documentation.
• Awareness of ALCOA+ and perform all required activities to support data integrity goals as required with minimal right first time issues.
• Understands how own work fits into the overall department goals, KPIs and can assess the impact of changes and work to meet set targets and timelines.
• Good communication (written and oral) with analysts to ensure analyses are signed off in a timely manner to meet the cycle time and deliverable targets.
• Discusses data review issues in a timely with the supervisor for guidance.
• Support the generation of analytical documentation for QC, Development and Raw Materials release activities (protocols, reports, COAs, specifications, ISR etc).
• Support raw materials release testing where required under minimal supervision.
• Support external testing requirements, including but not limited to requesting quotations and shipment of samples.
• Support stability pulls, setdown and stability sample disposal activities once adequately trained.

Application Requirements
When applying for a position with Quotient Sciences to be able to work in our organisation 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

Summary of job purpose

• To perform the review of analysis, documentation and raw data generated (including Empower and ELN) and recorded in compliance with GMP as per associated documentation.
• Author and review of analytical documentation.
• Involved in raw material release activities, external testing support and stability pulls and set down.
• Archiving of analytical documentations as required

Main tasks and responsibilities

• Support activities for data verification, review of laboratory data including lab notebooks, ELN, raw data packages (including Waters Empower) and Excel spread sheets etc.
• Ensuring all work being reviewed has been generated and recorded in compliance with GMP and as per SOP, test method, protocols or any relevant documentation.
• Awareness of ALCOA+ and perform all required activities to support data integrity goals as required with minimal right first time issues.
• Understands how own work fits into the overall department goals, KPIs and can assess the impact of changes and work to meet set targets and timelines.
• Good communication (written and oral) with analysts to ensure analyses are signed off in a timely manner to meet the cycle time and deliverable targets.
• Discusses data review issues in a timely with the supervisor for guidance.
• Support the generation of analytical documentation for QC, Development and Raw Materials release activities (protocols, reports, COAs, specifications, ISR etc).
• Support raw materials release testing where required under minimal supervision.
• Support external testing requirements, including but not limited to requesting quotations and shipment of samples.
• Support stability pulls, setdown and stability sample disposal activities once adequately trained