To maintain regulatory compliance through established programs for laboratory testing, maintenance, training, and SOPs within QC Chemistry
• Perform Chemical analysis on finished drug substance, drug product, in process materials and stability samples.
• Responsible for calibration and use of laboratory instrumentation.
• Complete documentation associated with analytical results in a timely manner.
• Report and document any non-conformances to the QC Supervisor.
• Assist in the preparation and review of area documentation (SOP’s, Reports, Protocols).
• Assist in the training of other analysts.
• Ensure training compliance within assigned work area and QC.
• Perform and assist in additional duties as directed by the QC Supervisor.
• Experience in High Performance Liquid Chromatography with Empower, Capillary Electrophoresis, Part Mat, Osmolality, pH, appearance testing, UV, Karl Fischer, SDS Coomassie.
• Experience with Lab systems an advantage. (LIMs, CDAS, Trackwise, PDOCs)
- A relevant third level qualification preferably.
- A minimum of 2 years previous laboratory work experience in a cGMP pharmaceutical environment.