Dosimetry Lab Supervisor

at  Abbott Laboratories

EDUCATION & EXPERIENCE

• Third level Science / Manufacturing or equivalent qualification.
• Minimum four years’ work experience in a Manufacturing / Science / Quality or equivalent environment.
• Electron beam or other sterilisation technologies experience desirable.
• Knowledge in ISO 11137 desirable.
• Chemistry/Microbiology/Dosimetry Lab experience desirable.

• Provide product and manufacturing support in a cGMP regulatory environment.
• Supervise, develop, and mentor employees within the team.
• Develop and drive the site dosimetry program, updating as appropriate.
• Manage and co-ordinate all the dosimetry lab activities, including coordination with providers and suppliers.
• Ensure that all work carried out is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs).
• Write documentation for dosimetry lab methods, equipment qualifications and equipment validation and provide guidance and feedback.
• Support laboratory set-up and maintenance of laboratory equipment and consumables.
• Drive the laboratory training program, knowing safety rules and regulations, and making sure all personal are trained on safe work practices.
• Review laboratory results, to ensure accuracy of data and timely communication of results.
• Ensure dosimetry lab is validated and controlled and comply with internal requirements, applicable regulations and ISO11137 standards.
• Provide technical guidance and support, in the areas of dosimetric release methods, dose mapping procedures and dosimetry curve calibration.
• Lead problem solving efforts related to dosimetric release and provide technical advice as required.
• Support unplanned events and raise out of specification results in a timely manner.
• Initiate and complete CAPAs and Change Controls in accordance with site procedures.
• Analyse product quality and process data using statistical techniques to identify trends and implement improvement plans accordingly. Generate and present quarterly and annual reports.
• Liaise with key business stakeholders; QA, Manufacturing, Engineering, R&D, Regulatory Affairs and Purchasing to ensure timely completion of activities.