Position maintaining regulatory compliance through, sample processing, laboratory testing, maintenance, training, SOP’s, validation and cleaning within the laboratory.
- Perform analysis on Raw Material, Intermediate, Stability samples and/or Finished Products.
- Laboratory support testing including consumable control and qualification.
- Validation and qualification of test methods
- Responsible for calibration and use of laboratory instrumentation.
- Perform and assist in additional duties as directed by the Supervisor.
- Complete documentation associated with test results in a timely manner.
- Report and document any non-conformances to the Supervisor.
- Preparation and review of area documentation (e.g. SOP’s, Reports, Protocols).
- Assist in the training of other analysts.
- Ensure training compliance within the assigned work area and QC.
- Adhere to safety systems within the laboratory and on site.
- 3rd level qualification in Microbiology
- A minimum of 3 years’ experience in a GMP Lab, (Bioburden, endotoxin)
- Strong analytical and problem solving ability.
- Ability to prioritise, demonstrating good time management skills.
Contact: Anne O’Donnell