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/manager and escalate any issues with testing, instrumentation or tasks that could impact on testing timelines.
- 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 GDP as required.
- Maintain Records to GDP 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.
- Champion QC Laboratory initiatives based on continuous improvement and 5S principles.
- 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 (collage hours can be used)
- Working Knowledge of how HPLC/GC/Wet Chemistry processes work in a lab
- Knowledge of cGMP/cGLP
- Proven track record of working within a team
- Bachelor’s degree
At Bimeda we are committed to fostering an inclusive, barrier-free and accessible environment. Part of this commitment includes arranging accommodations to ensure an equitable opportunity to participate in the recruitment and selection process. If you require an accommodation, we will work with you to meet your needs.
The job posting is available in an accessible format upon request by contacting the Human Resources Manager.