Quality Control Data Checker
As a Quality Control Data Checker within the CMC (Chemistry, Manufacturing & Controls) team, you will have responsibility to undertake routine checking of analytical qPCR data and reports generated within in the department.
The job responsibilities will include:
- Prepare accurate data tables and graphs, and maintain associated records and help maintain laboratory records
- Respond to Quality Assurance audit comments as appropriate
- Understand UK and international GLP, GMP and GCP regulations and their application to the work area
- Interpreting and analysing the results obtained from relevant studies and provide advice to department staff in data interpretation
- Developing, improving and validating qPCR analytical procedures, ensuring that these meet the objectives of the study and the scientific standards required by clients and regulatory authorities
- Liaising, on a limited basis, with the client, Company, Sponsors, preparing faxes and other communications as necessary
- Liaising with the Project Manager / Study Director / responsible Scientist on the performance of technical work involving projects, Studies performed within area of responsibility
Your experience and skill set:
- Ideally experience in drug development process within either a CRO or Pharmaceutical company and working in a regulatory environment, ideally GLP or GMP
- Experienced analyst in mainly PCR, ELISA, SDS Page, HPLC or Western Blot
- Excellent eye for detail- experience of performing quality control checking / review of raw data, reports etc
- Able to prioritise, with time management skills
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