Quality Control Chemist

Job Description

Job Description

We are seeking an experienced Quality Control Chemist to join our team in an FDA-regulated pharmaceutical manufacturing environment. This role is responsible for performing analytical testing, supporting laboratory investigations, validating analytical methods, and ensuring raw materials and finished products meet quality and regulatory standards. Sterile injectable pharmaceutical experience is required.

Responsibilities

• Perform analytical testing of raw materials, packaging materials, in-process samples, finished products, and utility systems.
• Prepare and maintain specifications, SOPs, test methods, and analytical documentation.
• Perform method validation, method transfers, and laboratory investigations (OOS/OOT).
• Review analytical data, Certificates of Analysis (COAs), and support batch release activities.
• Support quality systems including deviations, CAPAs, change controls, and quality risk assessments.
• Maintain laboratory equipment, calibration, qualifications, reagents, and reference standards.
• Ensure compliance with cGMP, GLP, FDA regulations, data integrity (ALCOA+), and Good Documentation Practices.
• Support internal audits, regulatory inspections, and continuous improvement initiatives.

Qualifications

• Bachelor's degree in Chemistry, Pharmacy, Pharmaceutical Sciences, Microbiology, or a related scientific field.
• 4–8 years of Quality Control experience in pharmaceutical manufacturing.
• Sterile injectable manufacturing experience is required.
• Hands-on experience with HPLC, GC, UV-Vis, FTIR, Dissolution, and Karl Fischer instrumentation.
• Experience with method validation, laboratory investigations, CAPA, and technical documentation.
• Strong analytical, troubleshooting, and communication skills.

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