Reporting to the QC Manager, this fast pace and varied role encompasses laboratory testing across a range of applications along with documenting and reporting of test results in a timely manner. Exceptional attention to detail and a drive for efficiency will be required, with a consistent and accurate approach to testing and documentation whilst adhering to all aspects of company and industry cGMPs. This role is a central part of the QC laboratory operation and supports the wider compliance and quality teams with a common goal for continuous improvement and achieving the company’s business strategy aligned with our Vision, Mission and values.
Key Role Requirements
- Conduct raw material, finished product, In-process, stability and water testing in accordance with SOPs and adherence to Good Laboratory Practices principles (GLP) whilst delivering to test schedule assigned.
- Complete testing and timely documentation write-ups in accordance with Good Documentation Practices (GDP) and delivery to Senior analyst/Designee for review.
- Notify Senior Analyst/Supervisor of any Out of Specification (OOS), Out of Trend (OOT) as soon as they occur.
- Author SOPs, protocols, change controls, reports in-line with GLP as required.
- Maintain Records to GLP in a timely manner, e.g. Lab Notebooks.
- Ensure workspace is hazard free and maintained in accordance with GLP.
- Ensure necessary equipment is within calibration and materials are available for testing.
- Ensure good adherence to test and lab operations scheduling as issued by the Senior Analyst.
- Carry out ancillary QC tasks, e.g. housekeeping, stock checking as required by the QC Manager/Supervisor or designee to ensure the QC laboratory operation runs seamlessly
Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.
- Experience working in a lab (college hours can be used)
- HPLC/GC/IC and Lab error/ OOS / OOT investigations experience
- Experience with CAPAs, Deviations and Change Controls.
- Proven track record of working within a team
- Bachelor’s degree