QC Scientist
On-siteSlough, England, United Kingdom
Job Summary
Perform analytical testing on therapeutic protein samples using techniques including HPLC, capillary electrophoresis, spectrophotometry and other physicochemical methods in accordance with GMP requirements, SOPs and study protocols. Review analytical data for technical accuracy, interpret results against specifications, identify trends and communicate observations to key stakeholders including Study Directors, Quality Assurance and Manufacturing. Prepare stability study protocols, testing summaries and technical reports to support product quality and stability programmes. Support investigations, deviations, CAPAs and change controls, independently leading routine quality investigations where appropriate. Mentor and support colleagues by sharing technical knowledge, providing training and promoting best laboratory practices. Contribute to laboratory operations through equipment monitoring, reagent and consumable management, housekeeping and continuous improvement initiatives. Work collaboratively across Quality Control, Quality Assurance and Manufacturing to ensure customer, regulatory and business requirements are consistently met.
Required Qualifications
- Degree in Chemistry, Biochemistry or another relevant scientific discipline, or equivalent relevant laboratory experience
- Experience working within a GMP-regulated pharmaceutical or biological laboratory environment
- Practical knowledge of analytical techniques such as HPLC, capillary electrophoresis, spectrophotometry or other protein characterisation methods
- Understanding of cGMP principles and their application within a quality-controlled laboratory
- Strong analytical and problem-solving skills with the ability to interpret data and identify trends
- Excellent organisational and communication skills with the ability to prioritise work and collaborate effectively within a multidisciplinary team
- A proactive mindset with a commitment to continuous learning, quality, safety and process improvement
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