QC Analyst to support the QC team in successful lab & site start-up
Are you a QC analyst looking for an exciting new opportunity?
I am currently recruiting for a QC analyst role which requires someone with 3+years experience.
Reporting to the QC Manger, the primary role of the QC Analyst is to support the QC team in successful Lab & Site start-up and implementation of associated systems as the site prepares for process validation and product launch activities.
· Perform, microbiological/biochemical/physical/chemical analyses of QC test samples under cGMP to meet specified timelines.
· Testing of finished product, raw materials, packaging and stability.
· Perform analytical testing - HPLC, SDS, FTIR, UV
· Evaluate results against defined acceptance criteria.
· Perform primary review of QC raw data and trend results.
· Prepare protocols, summaries, and reports-often for direct submission to pharmaceutical regulatory agencies.
· Develop, optimize, validate and troubleshoot analytical test methods.
· Draft QC SOPs.
· Act as technical resource and train other analysts in areas of expertise.
· Maintain the laboratory in an inspection-ready state.
· Interact directly with regulatory agency inspectors during audits.
· Conduct and document laboratory investigations.
· Interface with other departments (Manufacturing, Quality Assurance, Facilities, etc.) and contractors as necessary.
· Team Leadership - active participation team development.
· Successful track record in achieving goals as part of a team within a growing, dynamic environment.
· Demonstrated adaptability and flexibility to support a growing organisation.
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.