Independent authoring of oos oot deviation investigations
Advanced knowledge of kabitrack system
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Fresenius Kabi is seeking a Lead Scientist in Quality Control Chemistry with expertise in complex chemical analysis methods. The role involves ensuring compliance with laboratory regulations, training junior analysts, and conducting high-level testing and documentation.
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Job Summary
The Lead Scientist is responsible for performing high-level testing using advanced instrumental methods like HPLC and GC while ensuring strict compliance with cGMP regulations.
This role requires the incumbent to independently lead investigative studies for out-of-specification results and provide technical leadership to the Quality Control team.
Fresenius Kabi offers a comprehensive benefits package including medical, dental, vision, life insurance, disability coverage, and a 401(k) plan with company contributions.
Matching Summary
Match Score: 75
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Fresenius Kabi is seeking a Lead Scientist in Quality Control Chemistry with expertise in complex chemical analysis methods. The role involves ensuring compliance with laboratory regulations, training junior analysts, and conducting high-level testing and documentation.
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Salary
Base: $60,966 - $85,694 annually; Bonus/Equity: Not specified; Benefits: 401(k) with company contribution, paid vacation, holiday/personal days, EAP, medical/dental/vision
Skills & Requirements
Must-have
Expertise in HPLC GC TLC AA ICP-MS KF methods
Independent authoring of OOS OOT deviation investigations
Advanced knowledge of KabiTrack system
Strong understanding of cGMP GDP GLP practices
Ability to train and mentor less experienced analysts
Nice-to-have
Experience coordinating projects across multiple sites
Skill in summarizing findings concisely for management
Proven ability to learn new instrumentation quickly
Peer review experience for data accuracy
Key Requirements
Advanced training in specialized chemical analysis methods
Demonstrated expertise in chromatography techniques
Qualified Trainer status or equivalent mentoring capability