Analytical Operations Associate

Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. 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.

We are looking for an Analytical Operations Associate for our site in Reading. This is a part-time opportunity, 22.5 hours per week. In this role you will be required 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. The purpose of the role will also be to author and review analytical documentation. You will be involved in raw material release activities, external testing support and stability pulls and set down and 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 spreadsheets.
• 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.
• Good communication (written and oral) with analysts to ensure analyses are signed off in a timely manner.
• 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 requesting quotations and shipment of samples.
• Support stability pulls, setdown and stability sample disposal activities once adequately trained.

Qualifications and experience required for competent performance:

• Minimum HND/HNC or equivalent experience in a laboratory focused 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.

Please note, this is a part-time opportunity 3 days per week, 22.5 hours.

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.