QC Chemist

Role Description

The QC Chemist will perform routine and non-routine quality control testing on a variety of regulated products to ensure they meet established specifications and regulatory requirements. This full-time, on-site role is based in East Brunswick, NJ and involves conducting analytical testing, operating and maintaining laboratory instruments, and documenting results in compliance with CGMP and ISO 17025 standards.

• Prepare samples and reagents
• Execute validated methods
• Perform calibrations and system suitability checks
• Review data for accuracy, completeness, and adherence to internal SOPs
• Collaborate with the laboratory team to support product release, remediation, and stability programs
• Assist in investigations and out-of-specification (OOS) assessments
• Contribute to continuous improvement of laboratory processes
• Support audits and inspections
• Participate in method transfers
• Ensure all work aligns with data integrity and quality focus

Qualifications

• Demonstrated Quality Control expertise, including testing of raw materials, in-process samples, and finished products, and familiarity with CGMP and ISO 17025 requirements
• Strong Laboratory Skills encompassing sample preparation, solution and reagent handling, and adherence to safe laboratory practices and chemical hygiene
• Applied Analytical Skills in chromatography (e.g., HPLC, GC), spectroscopy (e.g., UV-Vis), and related techniques, with the ability to interpret data and troubleshoot analytical issues
• Hands-on experience with Laboratory Equipment operation, maintenance, and documentation, including balances, pH meters, and analytical instruments used in QC environments
• Proficiency in Calibration activities, such as routine calibration and verification of instruments and equipment, and proper recording of calibration records
• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences