Category: Scientific & Clinical
Title; QC Chemist
Hours: Full Time
Location: Summit, NJ
- Assisting with laboratory analysis for clinical and development release and routine stability testing. Conduct routine release and stability analyses of developmental (no commercial) compounds, prototype formulations and finished products in support of clinical testing for IND and NDA submissions. Perform laboratory analysis under guidance of a supervisor or designee.
- Conduct testing independently and may assist other analysts in analytical testing including HPLC, UPLC, GC, spectroscopy, dissolution, Karl Fischer, UV/Vis and other analytical laboratory testing.
- Conducts multiple analytical experiments using analytical methods and procedures.
- Draws basic conclusions from data and results and communicates with other analysts and management.
- Performs instrument/method troubleshooting within analytical method parameters and management guidance.
- Performs testing for development and clinical samples, release and stability samples in accordance with established methods, specifications and protocols with limited supervision.
- Good laboratory documentation skills. Understands cGMP documentation requirements.
- Documents/reviews laboratory work using laboratory notebooks/worksheets that is detailed, timely and in compliance with GLP/cGMP requirements.
- Other duties as assigned by management.
- BS/MS Chemistry or relevant discipline with equivalent experience.
- Minimum 2 - 4 years recent cGMP/GLP pharmaceutical laboratory experience.
- Experience with HPLC, UPLC, GC dissolution, FT-IR, UV/Vis spectrophotometry, KF.
- Experience w/ clinical release, clinical stability, validation, method transfer
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.