AR&D CHEMIST II

Formulated Solutions - Largo, FL

Full-time - Mid Level

Largo, FL

Chemical Manufacturing

About the position

The AR D Chemist II position at FORMULATED Solutions LLC involves the development, transfer, and validation of analytical methodologies including HPLC, Gas Chromatography, ICP, and AA. The role requires extensive cGMP experience and the ability to provide leadership and mentoring to junior chemists in the Quality Control Laboratory. The chemist will ensure compliance with Good Laboratory Practices and Good Documentation Practices while performing various testing and validation activities.

Responsibilities

• Develop, transfer, and validate analytical methods.
• Revise and write Validation Protocols, Test Methods, Validation Reports, and SOPs.
• Test incoming materials using compendial test methods (USP, PhEUR, JP).
• Test stability samples, in-process samples, and finished products using techniques such as HPLC, GC, AA, ICP, UV/Vis.
• Accurately record raw data and analyze, calculate, and interpret results.
• Investigate out of specification test results and implement corrective actions.
• Ensure compliance with GLP, cGMP, cUSP, SOP, and other approved test methods and protocols.
• Maintain analytical reagents in the laboratory, including inventory and MSDS management.
• Assist Validation teams in cleaning validation activities.
• Support laboratory troubleshooting needs by interacting with vendors and customers.
• Promote GMP and safety throughout the facility.
• Follow up on OOS's and CAPAs to verify compliance.

Requirements

• Bachelor's degree in Chemistry or related discipline.
• Three or more years of experience working in an analytical laboratory in an FDA regulated industry.
• Knowledge of compendial testing and chemical safety.
• Expertise in various analytical equipment and techniques including HPLC, GC, ICP, and AA.
• Ability to communicate effectively in a professional manner.

Nice-to-haves

• Experience in writing Standard Operating Procedures, Protocols, and Reports.
• Ability to troubleshoot HPLC, GC, ICP, and AA analyses.
• Experience in a dynamic fast-paced environment.