Perform routine tasks in the Quality Operations Laboratory in compliance with cGMP, GLP and Laboratory Safety practices.
· Perform chemical and physical testing of all raw materials, in-process materials and finished products to ensure it meets the
· Ensure laboratory results are accurate and of the highest quality.
· Ensure testing is conducted in a timely manner and review out of specifications results, conduct investigations to identify the root
· Ensure proper documentation for all tests and other activities performed.
· Calibrate, operate and maintain analytical instrumentation for product testing, including routine preventative maintenance and
· Write, revise and review Standard Operating Procedures, Protocols and Reports.
· Perform method development, validation and verification.
· Coordinate with other departments to ensure proper priority is given to the necessary rush orders to meet client demands.
· Perform any other assignments as assigned by QA/QC Manager.
Review and release raw material lots, bulk product batches and finished product batches. Assists in establishing and conducting annual GMP and GLP audits.
Employee uses professional skills and concepts to solve a variety of often complex situations. Able to make clear and concise decisions of vast importance in a limited period of time.
Communication and Interface:
This position interfaces mainly with QC and operations. Must have strong communication skills, both verbal and written, due to the high level of interface and position responsibilities. Must be able to read, write and speak English.
This position does not have direct reports.
Chemist II must have a bachelor’s degree in Chemistry or related science. Familiar with basic analytical techniques (HPLC, UV/Vis, FTIR, GC, ICP-MS, UPLC etc.). Must have experience with method validation.
Long periods of sitting, standing, also bending, stooping, reaching, lifting. Will work around powders and other chemicals. Protective eyewear is required to be worn when in the lab.