QC Chemist / Sr. QC Chemist
Senior QC Chemist / QC Chemist
Boca Raton, FL | Onsite
Sterile Injectable Pharmaceutical Manufacturing
Full-Time
About the Job
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.
Key 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
Qualifications
- 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.
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