This role sits within the Development lab for a global pharma company focusing on Oncology products.
The primary tasks and responsibilities of the position are as follows.
- Receiving and logging samples into the Laboratory.
- Analysing raw material, in-process, finished product and stability samples associated with development products according to specifications.
- Performing analytical method validations and investigational testing as directed
- Recording results in a timely and accurate fashion.
- Ensuring the Right First Time KPI with respect to Analyst's documentation are achieved.
- Reviewing co-workers/analyst documentation (i.e. Buddy System)
- Ensuring that all Quality Systems within the department are adhered to on a daily basis.
- Ensuring correct labelling of laboratory reagents and samples.
- Troubleshooting any erroneous analytical data obtained (Involvement in Lab Investigations Reports)
- Helping to ensure laboratory SOPs and specifications are kept up to date and in a state of compliance.
- Training other laboratory staff as requested and appropriate.
- At least 2 years' experience working within a cGMP environment (HPRA and FDA approved).
- A minimum of a BSc in a science related discipline.
- Extensive analytical testing experience with LC-MS (Desired Level: Subject Matter Expert)
- Ability to critically review analytical data. Possessing excellent attention to detail is a must.
- Ability to troubleshoot, identify analytical issues and follow up with corrective actions.
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.