Quality Control Analyst II

Responsibilities:

• Perform routine and non-routine chemical testing of commercial, validation, and stability samples per written methodology.
• Conduct qualitative/quantitative analyses using HPLC, GC, UV/Vis, KF, and FTIR.
• Use LIMS and Empower to acquire/process analytical data.
• Compare results to approved specifications; notify management of OOS/aberrant results.
• Participate in root cause problem solving; provide input for CAPA.
• Maintain lab equipment; perform metrology calibrations and preventative maintenance.
• Create/maintain GMP lab records; demonstrate “Right First Time.”
• Maintain clean/safe environment; follow safety procedures.
• Contribute to continuous improvement, communicate with team/vendors, and participate in daily huddles and 1:1s.

• Bachelor’s degree required.
• Minimum 3 years’ experience in a pharmaceutical or similar regulated environment.

• Basic knowledge of USP, cGMP, and FDA regulations.
• Use Empower and integrated LMS systems.
• Experience calibrating HPLC/GC systems.
• Ability to maintain/diagnose/work on lab instrumentation.

• Prioritize work; troubleshoot methods/instruments; independent work with limited supervision.

• Comprehensive health insurance, 401(k) match, Paid Time Off, company-paid life/disability.