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Senior Analytical Chemist

2 months ago


Lynwood, California, United States PL Developments Full time
Job Summary

We are seeking a highly skilled and experienced Senior Analytical Chemist to join our team at PL Developments. As a key member of our Quality Control department, you will be responsible for performing complex analytical testing and troubleshooting on various laboratory equipment.

Key Responsibilities
  • Perform Advanced Analytical Testing: Conduct thorough analysis of raw materials, in-process, and finished products using state-of-the-art analytical equipment such as HPLC, FTIR, UV, GC, ICP, and Wet Chemistry techniques.
  • Troubleshoot and Maintain Laboratory Equipment: Identify and resolve issues with critical lab instruments, ensuring minimal downtime and optimal performance.
  • Develop and Validate Analytical Test Methods: Collaborate with cross-functional teams to design, develop, and validate new test methods, ensuring compliance with FDA cGMPs, cGLPs, USP, ICH, SOPs, and other recognized standards.
  • Train and Mentor Laboratory Analysts: Provide guidance and training to junior analysts on analytical test method procedures, equipment operation, and documentation.
  • Communicate Test Results and Data: Effectively communicate laboratory test data, data review, and reporting of Out-of-Specification (OOS), Quality Review (QR), and Out-of-Trend (OOT) test results to the laboratory manager.
  • Participate in Laboratory Improvement Initiatives: Contribute to the implementation of the 5S process improvement program, identifying areas for efficiency improvements and suggesting solutions.
  • Ensure Compliance with Safety and Pharmaceutical Regulations: Adhere to all general safety and pharmaceutical compliance requirements, including OSHA regulations and company safety policies and procedures.
  • Coordinate with Calibration Services: Collaborate with external calibration services to ensure the upkeep of laboratory instrumentation.
  • Lead Laboratory Investigations and Draft Reports: Conduct thorough investigations and draft final reports for review by management, ensuring accurate and timely communication of laboratory findings.
Requirements
  • Education and Experience: Bachelor's degree in Chemistry or Biochemistry, with a minimum of 5-8 years of experience in a FDA-regulated environment, working in a QC laboratory.
  • Technical Skills: Strong foundation in analytical techniques, hands-on experience with sample preparation, and operation of analytical equipment and software. Proficiency in HPLC, GC, FTIR, UV Spec, ICP, and other analytical instrumentation. Experience with data analysis (MS Excel) and proficiency in MS Word required.
  • Physical Demands: Ability to frequently lift and/or move up to 25 lb, occasionally lift and/or move up to 35 lb, and regularly stand, sit, and walk to perform tasks.