Senior QC Chemist – Method Validation & Analysis

Hikma Pharmaceuticals; Bedford (OH); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Annual bonus

401(k) match

Paid time off 20 days

Personal days

Comprehensive benefits

Employee discount

Job summary

Hikma Pharmaceuticals USA Inc. Bedford site is seeking a Chemist III to execute testing in the Chemistry laboratory, including TOC, conductivity, nitrates, FTIR, chromatography, and QC testing.

The role includes designing test protocols for equipment and method qualification, writing quality records, and training Chemist I-II or QC Lab Technicians to perform routine laboratory testing while ensuring cGMP/cGLP compliance.

Qualifications

• Bachelor degree in science or related discipline (chemistry or chemical engineering).
• Minimum 5 years in a similar position in a cGMP environment.
• Thorough CGMP and FDA knowledge for laboratory operations.
• Ability to troubleshoot laboratory instruments and mentor peers.
• Strong analytical, detail-oriented, and interpersonal skills.

Responsibilities

• Maintain a safe laboratory environment and comply with OSHA and safety standards.
• Perform TOC, conductivity for WFI, nitrates via wet methods, FTIR, chromatography; QC activities.
• Qualify equipment with IQ/OQ/PQ protocols and generate reports.
• Assist in method validation/verification and tech transfer activities.
• Review and approve test data, SOPs, procedures, and validation reports.
• Train Chemist I-II or QC Lab Technician to perform testing using OJT documents.

Skills

CGMP knowledge

Troubleshooting

Mentoring peers

Project management

Analytical skills

Attention to detail

Interpersonal skills

Education

Bachelor Degree in Science or related discipline

Job description

Hikma Pharmaceuticals USA Inc. Bedford site is seeking a Chemist III to execute testing in the Chemistry laboratory, including TOC, conductivity, nitrates, FTIR, chromatography, and QC testing.

The role includes designing test protocols for equipment and method qualification, writing quality records, and training Chemist I-II or QC Lab Technicians to perform routine laboratory testing while ensuring cGMP/cGLP compliance.