Position Summary:

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

Qualifications:

• 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)