• Work on complex problems in which analysis of data requires an in-depth evaluation of various factors.
• Exercise judgment within broadly defined procedures and practices to select technique, methods, and evaluation criteria for obtaining results.
• May determine methods and procedures on new assignments and provide guidance for new or less experienced personnel.
• Able to solve problems and make decisions with minimal assistance.
• Able to interpret analytical data (including FT-IR, 1H NMR, MS).
• Write stability protocols, maintain stability chambers/programs, review/manage stability reports, interact with customers to support stability program.
• Develop testing methods to support cleaning verification program; validate or verify methods as necessary.
• Perform cleaning verification by executing existing methods.
• Perform review of analytical data for accuracy and quality.
• Train new or less experienced personnel in SOP content, analytical techniques, and instrument use.
• Meet with internal project groups to keep projects on track.
• Maintain projects and timelines with minimal oversight.
• Execute method transfers into QC and write summary reports.
• Perform method validations and write technical reports.
• Perform instrument calibration (IQ/OQ/PQ/PM) and routine equipment maintenance/repair.
• Analytically test in-process, final products, intermediates, and raw materials. Testing will involve the use of HPLC, GC, KF, DSC, TGA, IR, MS, NMR and XRPD among other tests and instruments.
• Participate in OOS investigations via testing and good documentation.
• Apply critical thinking and good problem-solving skills to thoroughly investigate deviations, identify root causes, and propose appropriate corrective/preventive actions with minimal assistance from supervisor
• Perform requalification of reference standards, and maintain reference standard inventory/documentation.
• Write and revise SOPs including raw material, intermediate, and final product specifications.
• Document testing properly and in a timely fashion, including keeping laboratory notebooks accurate and up to date.
• Demonstrate proper laboratory techniques.
• Work cooperatively within the QC department and with other departments to achieve project goals. Communicate with project management and provide technical updates
• Work in compliance with effective procedures and regulatory requirements outlined in ICH Q7 and 21 CFR Parts 11, 210 and 211 as applicable
• Work in a safe manner and maintain the cleanliness of the work environment.
• Work in accordance with FDA, OSHA, EPA, DNR, DOT, and other regulatory agency guidelines.