Job Title: Chemistry Analyst, Quality Control
Department: Quality Control
QC Chemistry - Job Purpose:
To maintain regulatory compliance through established programs for laboratory testing, maintenance, training, and SOPs within QC Chemistry.
Job Responsibilities for the QC Chemistry Analyst:
- 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 with a minimum of 6 months previous laboratory work experience in a cGMP pharmaceutical environment.