Job Description

Job Title: QC Chemist

Location: Raleigh, NC

We are seeking a skilled QC Chemist to join our Quality Control team. The ideal candidate should have experience with analytical method transfer and Inductively Coupled Plasma (ICP) analysis. This role involves supporting method validation, transfer, and troubleshooting of analytical techniques while ensuring compliance with regulatory standards and company policies.

Key Responsibilities:

• Assist in method transfers, validations, and verifications for analytical procedures following regulatory guidelines (FDA, USP, ICH, and cGMP).
• Perform ICP-OES and/or ICP-MS analysis on raw materials, intermediates, and finished products.
• Support troubleshooting and optimization of existing analytical methods to improve accuracy and efficiency.
• Execute test protocols and assist in preparing reports related to method validation and transfer.
• Maintain laboratory documentation and ensure compliance with SOPs and Good Laboratory Practices (GLP).
• Collaborate with senior chemists and cross-functional teams to support quality control and product development.
• Ensure laboratory instruments are calibrated and maintained as per schedule.
• Assist in investigations of deviations and out-of-specification (OOS) results, supporting corrective and preventive actions (CAPAs).
• Stay informed about industry trends and regulatory updates in analytical techniques.

Required Qualifications:

• Hands-on experience with ICP-OES or ICP-MS analysis.
• Experience in method transfer and validation of analytical methods.
• Ability to follow test protocols and assist in writing technical reports.
• Knowledge of regulatory guidelines and compliance (FDA, USP, ICH, cGMP).
• Experience with laboratory documentation and SOPs.

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