Research Associate II, Quality Control

Principal Duties And Responsibilities

• Support QC analytical chemistry testing using laboratory equipment and instrumentation (HPLC, UPLC, GC, KF, Dissolution etc).
• Author technical reports as required.
• Ensure instrument calibration and qualification is up to date and performed on a scheduled basis.
• Troubleshoot any issues with instrumentation and coordinate repair with vendors as necessary.
• Cook with scheduling of testing for reagents and product samples.
• Participate in data review.
• Participate in method development and validation activities.
• Cook with external outsourcing of testing.
• Support CAPA, change controls, investigations, and deviations and the timely closure of these items with Quality Assurance.
• Follow Good Documentation Practices (GDP), maintaining contemporaneous records, filling out logbooks, forms, etc.
• Adherence to cGMPs at all times.

Requirements

• Bachelor’s degree in Chemistry or related field
• 2+ years of work experience in a GMP Quality Control environment
• Prior experience with HPLC and UPLC
• Knowledge of CFR 210,211, USP and FDA/ICH guidance is preferred
• Knowledge of safe laboratory practices
• Strong verbal and written communication skills
• Experience with USP App IV dissolution apparatus is preferred