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)
• Required to use hands to handle objects, equipment, computer controls.
• Required to lift up to 50 lbs., stand, bend for extended periods of time.
• Specific vision abilities required include close vision, ability to focus.
• Required to be present in the laboratory to perform daily testing and collaborate with department director, peers, and supervisors.
• Responsible for compliance with all rules and regulations pertaining to safety policies with the proper attitude toward safety and health, helping to ensure that all department operations are performed with the utmost regard for the safety and health for all personnel.
• Hours/Travel maybe subject to changed based on management/company discretion.
• For exempt employees, casual or incidental overtime worked is not compensable. When these extra efforts are either infrequent or of short duration, it is expected that exempt Employees will consider these extra hours per day, part of their professional employee/Company relationship and extend their efforts without additional compensation.