Associate Analyst, QC Chemistry
Phoenix Metro Area, AZ
1. Responsible for assisting with laboratory analysis for commercial release and routine stability testing.
2. May conduct routine release and stability analyses of developmental and commercial compounds, prototype formulations and finished products in support of clinical testing for IND and NDA submissions.
3. Perform laboratory analysis under guidance of a supervisor or designee.
Responsibilities will include, but are not limited to, the following:
Able to conduct testing independently and may assist other analysts in analytical testing including HPLC, dissolution, Karl Fischer, UV/Vis and other analytical laboratory testing.
Conducts routine 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 commercial 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 (if worker isn't aware of GMP regulations, they are probably not a fit) ... or at least working in a regulated laboratory environment.
Experience with HPLC (chromatography) is a PLUS, dissolution, FT-IR, UV/Vis spectrophotometry, KF, etc.
Compendial (USP) testing knowledge is a PLUS.
Good communication skills.
Able to work well in team environment to achieve results.
Exhibits sound scientific judgment based on reasonable assumptions and available information.