Lead QC Chemist: Advanced Analysis & Training

Fresenius Kabi USA

Wilson (NC)

On-site

USD 61,000 - 86,000

Full time

6 days ago
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Benefits offered by this job

Medical benefits
Dental benefits
Vision benefits
Life insurance
401K with company contribution
Wellness program

Job summary

Fresenius Kabi USA is seeking a Lead Scientist in Quality Control Chemistry to lead routine and complex analytical methods. The role focuses on ensuring compliance with cGMP and related lab regulations while supervising training of junior analysts.

The incumbent oversees method development, data review, and investigative documentation for OOS/OOT events and deviations, using advanced instrumental analyses and KabiTrack systems. Strong mentoring and leadership are expected.

Qualifications

  • Advanced training in specialized methods of analysis.
  • Ability to prepare and review investigations for OOS/OOT.
  • Strong knowledge of cGMP and GDP/GLP practices.
  • Experience training and mentoring analysts.

Responsibilities

  • Articulate work-related issues clearly to management and peers.
  • Performs high-level testing using instrumental methods (HPLC, GC, TLC, AA, ICP-MS, KF).
  • Coordinate projects and ensure regulatory compliance across sites when needed.
  • Independently author and direct investigations for OOS/OOT and deviations.
  • Lead training and mentoring of analysts as a Qualified Trainer.
  • Summarize findings from evaluations and investigations clearly.
  • Peer review of data to ensure accuracy and compliance.
  • Technical review of documentation, procedures and reports.

Skills

HPLC
GC
TLC
AA
ICP-MS
KF
Regulatory compliance
Documentation & data review
Process training & mentoring

Tools

KabiTrack

Job description

Fresenius Kabi USA is seeking a Lead Scientist in Quality Control Chemistry to lead routine and complex analytical methods. The role focuses on ensuring compliance with cGMP and related lab regulations while supervising training of junior analysts.

The incumbent oversees method development, data review, and investigative documentation for OOS/OOT events and deviations, using advanced instrumental analyses and KabiTrack systems. Strong mentoring and leadership are expected.

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