QC Analyst

As a QC Analyst, you will be responsible for ensuring continued Good Manufacturing Practice (GMP)- compliant activities within QC to support the manufacture and release of plasmid and gene therapy products.

Requirements

• Execute routine analytical testing to support timely release of product.
• Support testing at external contract labs for raw materials and final product.
• Operation and maintenance of laboratory equipment ensuring all equipment is calibrated and suitable for use in alignment with test schedule.
• Record Out-of-Specification, non-conformances, investigations and implementation of corrective action(s) where applicable.
• Assistance with the development and updating of SOPs and laboratory documentation.
• Ensure all training is undertaken in a timely manner as required to perform activities designated.
• Maintain QC facilities to meet GMP requirements, conduct necessary checks to support any health authority, customer/stakeholder site visits.
• Support with maintaining the Quality Management System and controlling of documents and assuring the data integrity of all data produced.
• Execution of equipment qualification and method validation/transfer when required.
• Propose and/or support the development and implementation of continuous improvement programs.
• Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures.
• Responsible for ensuring that own training is undertaken in a timely and GMP compliant manner before the task is undertaken.
• Responsible for ensuring that any GMP documentation assigned to me e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions are closed timely and in a RFT state.