Under general supervision, performs laboratory analyses of extractable and leachable samples, performs maintenance and calibration of analytical instruments, and processes data with scripts, and reviews script-processed data. Provides analytical support for other areas of product development, as requested, e.g., method development, product deformulation, and range finding studies. Essential Job Functions:Carries out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws.
Operates analytical instruments such as LC/MS, GC/MS, automatic titrator, IR, and others.
Performs all necessary calculations associated with the test analyses.
Performs analysis of extractable and leachable samples, stages and pulls studies, processes data with scripts and reviews script-processed data
Labels, transcribes and records documentation such as laboratory notebooks as required by Standard Operating Procedures (SOPs).
Cleans, maintains and calibrates laboratory equipment to ensure compliance with cGLP and cGMP.
Meets project deadlines and performance standards as assigned.
Complies with all Company policies and procedures, including safety rules and regulations.
Performs related duties as assigned.
One (1) year related laboratory experience or an equivalent combination of education and experience. Knowledge of: - Pertinent SOP's related to pharmaceutical laboratory testing, analyses and documentation.
- Chromatographic instrument operation methods and techniques.
- Business, scientific and personal computer hardware and software applications.
- Business English usage, spelling, grammar and punctuation.
Bachelor’s Degree in Science or related science field from an accredited college or university.