QC Chemistry Supervisor

at  Alexion PharmaceuticalsInc

THIS IS WHAT YOU WILL DO:

The QC Supervisor will support the QC Chemistry team. They will oversee the operation of a QC testing group by means of a hands on approach to laboratory operations and supervise a team of analysts. The supervisor will provide technical support with regard to method validation, method transfer, regulatory updates and new technology as required.

YOU WILL BE RESPONSIBLE FOR:

• Lead a team of analysts in QC Chemistry by coordinating daily operations and ensuring team members are trained in their job function and current revisions of relevant SOPs
• Ensuring high cGMP, GLP standards are maintained while testing and adherence to schedules and targets to meet regulatory and business requirements
• Ensure relevant assays are performed on samples in support of release test and stability test programs, including but not limited to: HPLC, UV, iclEF (lmaged Capillary isoelectric focusing), and Compendial assays
• Support any validation and qualification of test methods and processes as required
• Ensure audit readiness at all time
• Maintain regulatory compliance through the creation and maintenance of programs for laboratory testing, training, SOPs and validation.
• Preparation of documentation for audits carried out by internal auditors and Regulatory bodies.
• Facilitate laboratory investigations and support associated investigationsTroubleshoot laboratory methods and instrument problems.
• Represent the QC department in internal and external audits where appropriate and close out of actions/ recommendations identified from both internal and external audits.
• Investigate out of specification/limit results utilizing Structured Problem Solving, Root Cause Analysis tools in conjunction with the QC Manager, QA and other relevant departments and to implement effective corrective and preventative actions while ensuring all investigations are closed within the specified lead-time