Job Description

Description:

• Perform routine tests of finished product and stability samples, raw materials and CV samples, including, assays, chromatographic purity, content uniformity using UV and HPLC, particle size distribution using different techniques including, water determination by KF, and tests according to the in-house monographs and USP in a regulated laboratory environment. \xe2\x80\xa2 Evaluates test results and decide the acceptability of the samples based on the test results. \xe2\x80\xa2 Maintain accurate lab notebooks and complete all related analytical reports, write summaries, and keep proper documentation in compliance with SOPs. \xe2\x80\xa2 Maintain the laboratories with good housekeeping practices and in compliance with cGMP. \xe2\x80\xa2 Ensure notebooks are reviewed promptly, in accordance with SOPs. \xe2\x80\xa2 Analyze and interpret results in written and oral format. \xe2\x80\xa2 Assist in the training of new analysts. \xe2\x80\xa2 Conduct Laboratory investigations and initiate Quality Events, CAPA and Change Controls as needed \xe2\x80\xa2 Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment

Skills:

HPLC, chemistry, pharma , FDA, GMP, laboratory technician, scientist, chemist, uplc, sop

Top Skills Details:

HPLC, chemistry, pharma , FDA, GMP, laboratory technician, scientist, chemist

Additional Skills & Qualifications:

Role Summary Perform testing and decide on the acceptability of the in-process, process validation samples, finished products, stability samples, raw materials, CV samples and developmental samples in a regulated laboratory environment. Analyze and interpret results in a written and oral format. Essential Duties and Responsibilities \xe2\x80\xa2 Perform routine tests of finished product and stability samples, raw materials and CV samples, including, assays, chromatographic purity, content uniformity using UV and HPLC, particle size distribution using different techniques including, water determination by KF, and tests according to the in-house monographs and USP in a regulated laboratory environment. \xe2\x80\xa2 Evaluates test results and decide the acceptability of the samples based on the test results. \xe2\x80\xa2 Maintain accurate lab notebooks and complete all related analytical reports, write summaries, and keep proper documentation in compliance with SOPs. \xe2\x80\xa2 Maintain the laboratories with good housekeeping practices and in compliance with cGMP. \xe2\x80\xa2 Ensure notebooks are reviewed promptly, in accordance with SOPs. \xe2\x80\xa2 Analyze and interpret results in written and oral format. \xe2\x80\xa2 Assist in the training of new analysts. \xe2\x80\xa2 Conduct Laboratory investigations and initiate Quality Events, CAPA and Change Controls as needed \xe2\x80\xa2 Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment Education & Experience \xe2\x80\xa2 Bachelor\'s degree in Chemistry or related scientific field and 1-2 years related experience in pharmaceutical analysis OR Master\'s degree in Chemistry or related scientific field and 1 year related experience in pharmaceutical analysis. \xe2\x80\xa2 To perform this job successfully, an individual should have: \xe2\x80\xa2 Ability to deal with problems involving several concrete variables in standardized situations. \xe2\x80\xa2 Ability to carry out necessary computations and to draw and interpret graphs. \xe2\x80\xa2 Working knowledge of instrumentation software used in the laboratories. \xe2\x80\xa2 Aid in the writing of labor

Experience Level:

Entry Level

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We\'re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Actalent