- Job Level:
We are currently looking for someone to fulfill an opening we have in Quality Control to perform routine testing and decides on the acceptability of the in-process, process validation samples, finished products, stability samples and developmental samples in a regulated laboratory environment. Analyze and interpret results in written and oral format. 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.
Our client researches, develops, 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.
- Evaluates test results and decides 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.
- Analyze and interpret results in written and oral format.
- Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment and Safety Practices.
- Bachelor’s degree in Chemistry or related scientific field 2+ years related experience in pharmaceutical analysis.
- Master’s degree in Chemistry or related scientific field 1+ year related experience in pharmaceutical analysis.
Experience & Skills Required
- 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.
- Aid in the writing of laboratory practices and procedures.
- Helps assist in the generation of laboratory practices and modifications of standard operating procedures.
- Assist in the validation of QC methods.
- May lead and direct the work of others.
- A wide degree of creativity and latitude is expected.
- Knowledge of Excel and MS Office Suite Word Processing software.
- Excellent communication skills, including the ability to speak clearly, listen and gain clarification, respond well to questions, and write clearly and informatively.