Job Description

Role: Sr QC Chemist

Location: Lincoln, NE

Duration: 6+ Months

Position Overview:

We are looking for an experienced Senior QC Chemist with specialized knowledge in method transfer and Inductively Coupled Plasma (ICP) analysis to join our Quality Control team. The successful candidate will lead method validation, transfer, and troubleshooting of analytical techniques while ensuring compliance with regulatory standards and company policies.

Key Responsibilities:

• Lead method transfers, validations, and verifications for analytical procedures, adhering to regulatory guidelines such as FDA, USP, ICH, and cGMP.
• Develop and execute test protocols and generate comprehensive reports for method validation and transfer.
• Perform and optimize ICP-OES and/or ICP-MS analyses for raw materials, intermediates, and finished products.
• Troubleshoot and enhance existing analytical methods to improve accuracy, precision, and operational efficiency.
• Compliance and Documentation:
• Review and approve laboratory documentation to ensure compliance with Standard Operating Procedures (SOPs) and Good Laboratory Practices (GLP).
• Assist in investigations, managing deviations and out-of-specification (OOS) results, and implementing Corrective and Preventive Actions (CAPAs) as necessary.
• Train and mentor junior chemists and laboratory staff on advanced analytical methodologies and best practices.
• Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory departments, to support product development and quality assurance initiatives.
• Instrument Maintenance and Industry Awareness:
• Ensure proper maintenance, calibration, and preventive care of laboratory instruments.
• Stay informed about industry trends, regulatory updates, and advancements in analytical technologies.

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