For services in the Quality area WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree in Natural Science in Biochemistry or Chemistry and five (5) years of exposure within the Pharmaceutical Industry. At least two (2) years of exposure in method development - transfer of biomolecules is preferred. Shift: Administrative and willing to work extended hours and or weekends if necessary. Experience in: Equipment Validation Expertise (URS, DQs, Validation Master Plan PQ) Maximo application user Infinity application user The Personality Part: If you have a commitment to serving customers with high-quality research and products, to embracing a diverse work culture, and even to the environment, you might just be what we're looking for! AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Designs, executes and evaluates method development protocols to ascertain the required degree of validation for new and existing methods guaranteeing implementation of a feasible, efficient, rugged, and robust method. Supports technical aspects of test method ruggedness and robustness processes. Supports the Analytical Ruggedness Project Manager and Quality Control to gather information on investigations, troubleshooting, method deviations, method optimization, and method change control. Coordinates projects to assure successful and timely execution, issuance and updating of detailed time and event schedules. Leads analytical special projects to accomplish company goals and objectives on a timely and effective manner. Support laboratory instrument qualification including knowledge in Maximo, Infinity Generate IOQ and PQ reports for the qualification of Analytical Instruments Provides timely and efficient technical reports to document all analytical improvement or investigation projects. Evaluates and appraises method and instrument changes in regard to regulatory requirements. Keeps current with emerging technologies, new instrumentation, and regulatory expectations relative to the pharmaceutical/development laboratory operations. Trains Technical Operations analysts to perform existing and/or new analytical methods and generate training. Verifies consistency with other site procedures and/or specification. Verifies compliance with BMS Policies and Guidelines. WHO WE ARE: We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS! Are you the Next Piece? Powered by JazzHR
