Chemist - Wilson, United States - AgreeYa Solution Inc.
1 month ago
Description
Performs a variety of chemical analysis and GMP reviews of raw materials packaging components ancillary solutions in-process samples finished product and stability samples in accordance with cGMP GLP DEA and company policies and procedures.
Assists in writing and performing method validations and method transfers. Assists in process validations. Conducts equipment validations IQs OQs PQs and MQs if necessary.Provides assistance and technical support to other groups with chemical testing needs and performs troubleshooting of analytical methods and instrumentation.
Summary of Work Entry-level Chemist (Quality Specialist I) 0-2 years' experience HPLC Dissolution testing LIMS and Empower software experience is a perk.
Necessary Knowledge Skills and Abilities Must demonstrate comprehension of at least one analytical technology (HPLC GC Dissolution Automation or Spectroscopy – UV/Vis NIR IR or AA/AE); and should have a familiarity with cGMPs and FDA requirements.
Must pass an internal GMP Training course and be computer literatePrimary Responsibilities Perform all assigned testing in a timely and organized manner in accordance with cGMP GLP DEA and company policies and procedures.
Accurately document all necessary and relevant information in