- Job Level:
We are currently seeking a QC Chemist to perform routine testing and determine the acceptability of the in-process, process validation samples, finished products, stability samples, and developmental samples in a regulated laboratory environment.
Our client researches, developments, and manufactures pharmaceutical products. Their talented and diverse workforce enjoys an array of benefits, including 401k with employer matching, medical, and dental coverage where applicable. The company's overarching mission is to empower their employees to grow professionally and advance their careers within the organization. Their dynamic team truly enjoys the opportunity to be involved with a company that impacts lives in a positive way.
- Perform routine tests of finished product and stability samples including dissolution, assays, chromatographic purity, content uniformity using UV and HPLC, particle size distribution using different techniques including Light Scattering (e.g. Malvern), density, water determination by KF, and tests according to the in-house monographs and USP in a regulated laboratory environment.
- Evaluate test results and decide on the acceptability of the samples based on the test results.
- Maintain accurate lab notebooks and complete all related analytical reports, write summaries, and keep proper documentation in compliance with SOPs.
- Maintain the laboratories with good housekeeping practices and in compliant with cGMP.
- Ensure notebooks are reviewed in a timely manner, in accordance with SOPs.
- Design and develop test methods, perform experimental tests and evaluate performances.
- Write test methods, method validation protocols and reports. Establish test specifications and communicate with internal and external customers.
- Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment and Safety Practices.
Experience & Skills Required
- Bachelor’s degree in Chemistry or related scientific field with 2+ years of related experience in pharmaceutical analysis OR a Master’s degree in Chemistry or related scientific field with 1+ year related experience in pharmaceutical analysis.
- Ability to deal with problems involving several concrete variables in standardized situations.
- Ability to carry out necessary computations and to draw and interpret graphs.
- Working knowledge of instrumentation software used in the laboratories.
- Ability to aid in the writing of laboratory practices and procedures & experience with assisting in the generation of laboratory practices and modifications of standard operating procedures.
- Knowledge of Excel and MS Office Suite Word Processing software.