Quality Control Scientist - Chromatography Specialist

ChromaGenix; Raleigh (NC); On-site; USD 65,000 - 90,000; Full time

Job summary

ChromaGenix in Raleigh, NC seeks a Quality Scientist to establish a dedicated QC function, collaborating with R&D and quality teams to deliver analytical support, method development, and validation for peptide ligand technology and finished products.

The role includes supporting chromatography characterization (HPLC/UPLC/GC), routine batch release testing, data integrity, and regulatory compliance (ISO9001, GMP, GLP).

Qualifications

• Degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Life Sciences, or related field.
• Proven experience in a regulated laboratory environment.
• Strong hands-on experience with chromatography techniques (HPLC, UPLC, GC).
• Excellent understanding of ISO9001, GMP, GLP, and laboratory quality systems.
• Experience investigating analytical issues, deviations, and non-conformances.

Responsibilities

• Perform and review chromatographic analyses using HPLC, UPLC, and GC.
• Support QC/QA activities in line with ISO9001, GMP, GLP and regulatory requirements.
• Review analytical data for accuracy and compliance with specifications.
• Lead and support investigations (CAPAs, deviations, OOS/OOT).
• Assist in development, optimization, transfer, and validation of analytical methods.
• Ensure data integrity and adherence to quality standards.
• Maintain instruments and coordinate calibration/maintenance.
• Prepare and review technical reports, SOPs, validation protocols, and quality docs.
• Support internal and external audits and regulatory inspections.
• Drive continuous improvements in lab and quality systems.

Skills

HPLC

UPLC

GC

Data analysis

Quality systems

Education

Bachelor's degree in Chemistry/Analytical Chemistry/Pharmaceutical Sciences/Life Sciences

Tools

HPLC systems

LC-MS

Job description

ChromaGenix in Raleigh, NC seeks a Quality Scientist to establish a dedicated QC function, collaborating with R&D and quality teams to deliver analytical support, method development, and validation for peptide ligand technology and finished products.

The role includes supporting chromatography characterization (HPLC/UPLC/GC), routine batch release testing, data integrity, and regulatory compliance (ISO9001, GMP, GLP).