Quality Control Chemist

Quality Control Chemist

Developing pharmaceutical CDMO in Boca Raton, FL is seeking an experienced Quality Control Chemist to join their team on a direct hire basis!

Responsibilities

• Review/test raw materials (RM), packaged materials (PM), in-process (IP), and finished products to ensure quality standards are met.
• Conduct method transfer and verification, including investigation of out-of-specification (OOS) and out-of-trend (OOT) results.
• Ensure laboratory compliance through audits and data integrity practices.
• Perform sampling and testing for raw and packing materials, managing distribution of work among 2-3 team members from sample collection to result generation.
• Prepare specifications for raw materials, packing materials, and finished products according to USP/US Pharmacopeia standards.
• Perform chemical testing using techniques such as FTIR, Karl Fischer titrations, and UV-Vis spectroscopy.
• Review and approve test limits and testing procedures based on pharmacopeial requirements.

Requirements

• BS/MS in Chemistry, Pharmacy, Pharmaceutical Sciences, Microbiology, or related discipline.
• 5-8 years of QC experience in pharmaceutical sterile injectable manufacturing.
• Experience with USP/US Pharmacopeia, including preparation of specifications and chemical testing.
• Proficiency in FTIR, Karl Fischer Titrations, and UV-Vis techniques.
• Strong knowledge of method transfer, investigations (OOS/OOT), and laboratory compliance.
• Ability to review data, perform audits, and maintain data integrity.