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Quality Assurance Specialist

2 months ago


New Brunswick, New Jersey, United States EPM Scientific Full time
Job Summary

We are seeking a highly skilled Quality Control Analyst II to join our team at EPM Scientific. As a key member of our laboratory team, you will be responsible for ensuring the quality and integrity of our pharmaceutical products.

Key Responsibilities
  • Instrumentation and Analysis: Perform routine analytical tests of pharmaceutical raw materials, in-process samples, blends, finished products, and stability samples using instrumentation such as HPLC, UPLC, GC, UV/VIS, FTIR, dissolution apparatus, particle size analyzer, etc.
  • Documentation and Reporting: Responsible for the timely execution of lab analysis and related documentation, including concurrent documentation of all raw data, observations, and results.
  • Quality Control and Assurance: Compile analytical data and notify results to supervisor, adhere to safety, DEA procedures, and department SOPs, and perform calibration of analytical instruments.
  • Method Development and Validation: Perform qualification of working standards, execute method transfer and method validation, and maintain clear and concise lab records and documentation.
  • Maintenance and Housekeeping: Perform routine maintenance of lab equipment as needed and maintain a clean and tidy working environment.
Requirements
  • Education and Experience: Minimum BS or equivalent degree in Chemistry or related discipline with a minimum of 4 years of pharmaceutical industry lab experience.
  • Knowledge and Skills: Knowledge of analytical instrumentation, hands-on experience with analytical instruments, experience with instrumentation troubleshooting, and familiarity with cGMP/GLP practices for analytical laboratories and EHS/OSHA safety regulations.