Responsible for the performance of a variety of routine and non-routine scientific tests utilizing laboratory apparatus, including the generation, analysis and recording of data, with less than daily supervision.
• Independently or with limited direction executes testing of all active substances, raw materials (excipients) and finished dosage forms according to defined procedures.
• Participates in the self-directed work team in prioritizing, scheduling and resource allocation in order to maintain efficient workflow to assure completion of schedules, fully synchronized with the Process Oriented Unit
• Ensure QC information and documentation is properly archived, tracked, trended and analyzed as needed
• Ensure that all activities are performed according to the local Quality System and SOP’s, as well as national and local regulations
• Demonstrate behaviors and positive attitudes in line with Quality Assurance values.
• Participates in or leads investigations of laboratory deviations and OOS results
• Assist in the resolution of routine, and non-routine, technical problems
• Participate in method validation and transfer, including authoring of protocols and reports
• Assist in training of other associates.
• Authoring and review of SOP's and test methods.
• Participate in, or lead, QC process improvement projects.
• May review and approve data.
• Performs other duties as may be required or necessary
• A minimum of a Bachelors degree in a scientific discipline is required. Equivalent experience may be accepted.
• A minimum of 3 year work experience in a research and/or development environment is preferred.
• Previous hands-on practical laboratory experience is required.
• Must have a demonstrated working knowledge of scientific principles.
• Must be able to demonstrate basic decision-making skills.
• Must possess good oral and written communication skills.
• Must be able to demonstrate sound judgment.
• Must have demonstrated problem solving abilities.
• Strong organizational skills are required.
• Good computer skills are required. Working knowledge of MS word, Excel, Power point is a plus.
• Experience working in an FDA regulated environment is highly desired.
• Must be willing to work as part of a team and demon-strate good interpersonal skills.
Novartis is an EEO/AA employer M/F/D/V