Job Title: Associate Scientist 2nd Shift

Job Description

We are seeking a dedicated Associate Scientist to join our team on the 2nd shift. This role involves performing routine tests on finished products, stability samples, raw materials, and CV samples, ensuring compliance with in-house monographs and USP standards in a regulated laboratory environment.

Responsibilities

• Perform routine tests on finished products, stability samples, raw materials, and CV samples, including assays, chromatographic purity, content uniformity using UV and HPLC, and particle size distribution using various techniques.
• Evaluate test results and determine the acceptability of samples based on the results.
• Maintain accurate lab notebooks and complete all related analytical reports, summaries, and documentation in compliance with SOPs.
• Ensure laboratories are maintained with good housekeeping practices and in compliance with cGMP standards.
• Review notebooks promptly in accordance with SOPs.
• Analyze and interpret results in both written and oral formats.
• 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.

Essential Skills

• Proficiency in HPLC, UPLC, UV-Vis, and related analytical techniques.
• Strong analytical background in chemistry.
• Experience with FDA and GMP regulated environments.
• 1-2 years of experience with HPLC.
• BS Degree preferably in chemistry, pharmacy, or related fields.
• Computer literacy and familiarity with analytical and/or process equipment used in laboratories such as HPLC, IR/FTIR, UV-Vis AA, powder blender.
• Effective English written and oral communication skills.

Additional Skills & Qualifications

• Experience with SOP documentation and compliance.
• Ability to assist in training new analysts.
• Experience conducting laboratory investigations and initiating Quality Events, CAPA, and Change Controls.

Work Environment

The position is based in a lab environment regulated by the FDA and GMP standards. The working hours are from 2:30 PM to 11:00 PM. Interviews will be held on Tuesdays and Thursdays from 2 PM to 4 PM.