QC Lab Technician

New Castle, DE

Position Summary

This role will report directly to the QC Supervisor.

 

Essential Duties and Responsibilities

  • Perform/document required laboratory testing to support in-process, finished product and the stability program. Analytical capabilities and experience must include but are not limited to:
    • HPLC analysis – refractive index detection
    • Gas Chromatography – Flame ionization detection
    • Karl Fischer / Water Content Analysis
    • Wet chemistry (titrations, identification tests)
    • Physical properties (refractive index, specific gravity)
    • Familiar with the USP / EP Pharmacopeia.
  • Ensure proper samples are collected and logged. This includes stability samples and study initiation.
  • Communicate results to Operations to support the processes.
  • Experience with LIMS a plus.
  • Initiate and complete OOSI investigations.
  • Maintain and revise test methods as needed.
  • Notify appropriate personnel when problems arise and work to resolve issues.
  • Approve plant cleaning operations.
  • Maintain the equipment calibration and maintenance programs
  • Maintain the laboratory supply inventory and requisition supplies as needed.
  • The ability to work independently with minimal supervision.

 

Interpersonal Skills

  • Honesty, integrity, and the ability to work collaboratively, respectfully and safely.
  • Effective clear and concise communication.

 

Supervisory Responsibilities

This position has no direct reports.

 

Education and/or experience:

  • Minimum 4-year chemistry degree or a degree in an applicable science. Individuals with considerable laboratory experience (5 years plus) will be considered.
  • Chromatography experience HPLC and GC.
  • Good Laboratory techniques with experience in a GMP environment.
  • The position is primarily a day shift position, but must be willing to work an extended day (12-14 hrs) two or three times per month. On rare occasions, it's necessary to work a Saturday.
  • Previous experience in a multi-tasking work environment.
  • Good documentation and communication skills

 

Travel Requirements:

The position is located at the New Castle, DE Plant.

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