A Chemist Level I is responsible for performing chemical testing and completion of real-time documentation per cGMPs and current SOPs.
Essential Job Functions:
• Perform UPLC, HPLC, GC, UV-vis, FTIR, ICP, TOC and wet chemistry testing
• Proficient in various UPLC and HPLC software programs, such as Empower and EZ-Chrom
• Assist in writing SOPs and Test Procedures following good documentation practice per company's SOP and cGMP regulations
• Assist in OOS investigations
• Perform routine laboratory chemical analysis on finished product, stability and/or raw material, also involved in performing Cleaning, Method and Process validation.
• Troubleshoot basic instrument problems with supervision
• Provide well-written, accurate and timely reports
• Perform all work using appropriate safety measures and following company Chemical Hygiene Plan.
• Strictly adhere to all applicable safety and standards guidelines such as SOP, cGMP, DEA regulations and/or MSDS.
• Maintain clean laboratory working surfaces, and disposes of excess chemicals, solutions, solvents, etc. in special waste receptacles as required
• Review data, reports and notebooks
• Assist in maintaining and troubleshooting laboratory equipment
• Provide general laboratory support; such as routine instrument cleaning/preventive maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping.
• Other responsibilities as assigned by management
• Bachelor’s degree in Chemistry required
• At least one year of experience working in pharmaceutical laboratory
• Experienced in use of HPLC/UPLC/ICP and in wet chemistry testing
• Experienced in Waters Empower 2 software.
Skills and Abilities:
• Perform some methods testing independently but may require guidance/supervision
• Operate some instruments independently on some methods but may require guidance/supervision
• Suggest improvements to existing testing methods when possible
• Able to perform Method Testing/Validation for projects as required
• Able to follow SOPs and TMs as required and on occasion suggest improvements
• Able to review analytical packages from some techniques performed in the lab by Chemists Level I or below (or by management approval).
• May be able cross-train Chemists Level I or below (or by management approval) on some techniques performed in the lab
• Perform investigational testing for OOS
• Participate in cross functional teams and make suggestions for laboratory (such as lab compliance, monitoring, ordering and implementing USP changes, etc)