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.
• Evaluates test results and decide 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 compliance with cGMP.
• Ensure notebooks are reviewed promptly, in accordance with SOPs.
• Analyze and interpret results in written and oral format.
• Assist in the training of new analysts.
• Conduct Laboratory investigations and initiate Quality Events, CAPA and Change Controls as needed
• Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment
Additional Skills & Qualifications:
• 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.
• To perform this job successfully, an individual should have:
• 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 labor
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
Actalent is an equal opportunity employer.
About Actalent
Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.