QC Chemist

Boca Raton, FL | Onsite | Full-Time

About the role

A growing pharmaceutical manufacturer is seeking a Senior QC Chemist / QC Chemist to support analytical testing activities within a sterile injectable manufacturing environment. This individual will play a key role in building and supporting laboratory operations at a rapidly expanding facility approaching commercial production. The position is highly hands-on and will support raw material, in-process, finished product, and stability testing while helping establish laboratory systems, procedures, and quality standards. This is an excellent opportunity for a strong pharmaceutical QC professional who enjoys working in a developing environment and wants to have a direct impact on a growing operation.

Responsibilities

• Perform analytical testing of raw materials, in-process materials, finished products, and stability samples
• Operate and troubleshoot analytical instrumentation including HPLC, GC, FTIR, UV-Vis, dissolution systems, and Karl Fischer titrators
• Support laboratory investigations including OOS, OOT, deviations, and CAPAs
• Execute and support analytical method validation, method transfer, and method suitability activities
• Prepare and maintain specifications, analytical procedures, and laboratory documentation
• Support equipment calibration, qualification, and routine maintenance activities
• Review analytical data and laboratory records to ensure compliance with GMP requirements
• Support preparation and review of Certificates of Analysis (COAs)
• Assist with laboratory audit readiness and regulatory inspection support
• Partner closely with Quality, Manufacturing, Validation, and Technical Operations teams
• Maintain compliance with cGMP, GLP, data integrity, and documentation requirements

Requirements

• BS degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or related scientific discipline
• 8+ years of pharmaceutical Quality Control experience preferred
• Strong pharmaceutical manufacturing background required
• Experience within sterile injectable, aseptic, parenteral, or other highly regulated pharmaceutical manufacturing environments strongly preferred
• Hands-on experience with HPLC required
• Experience with analytical instrumentation such as GC, FTIR, UV-Vis, Dissolution, and Karl Fischer preferred
• Experience performing analytical method validation and method transfer activities
• Understanding of OOS/OOT investigations, CAPAs, deviations, and GMP documentation
• Experience developing specifications, test methods, SOPs, and laboratory procedures preferred
• Strong knowledge of FDA-regulated pharmaceutical manufacturing environments

Ideal Background

• Pharmaceutical QC laboratory experience
• Sterile injectable manufacturing
• Analytical chemistry and wet chemistry testing
• Method validation and transfer
• GMP laboratory operations
• Stability testing
• Investigation ownership
• Startup or growing manufacturing environments

Relocation assistance may be available for qualified candidates.