Analytical Scientist will be responsible for providing direct analytical support to the larger Quality Analytical Services and Quality team, Technical Service and Operations. The Analytical Scientist will work within a dedicated Quality Analytical Services laboratory. The scope of work will include laboratory, strategy/test plan development, and analytical method validation activities for a broad range of materials and product types.
· Ability to efficiently and effectively learn and execute new analytical methods and procedures.
· Ability to follow a protocol effectively in order to execute a validation of an analytical method or procedure.
· Ability to organize data for a report
· Ability to follow a methods and calculate results
· Ability to execute methods from within the US Pharmacopeia General Chapters and Monograph
· Have good understanding of several areas of lab instrumentation (LC, GC, KF, IR, UV, DM)
· Document and maintain data/test results per GMP, produce protocols and reports; present results as required for management updates.
· Operate and maintain the QAS laboratory within GMP and SOP requirements and within budget.
· Perform other duties as deemed necessary by department management.
· Ensure that all data comply with cGMP, FDA and/or other appropriate regulatory guidelines.
· Work cooperatively with other QAS staff in other locations.