The Role

We are looking for an Analytical Operations Associate for our site in Reading. 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 of 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 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.

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.

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