Research Associate II, Quality Control

Position Summary

As a Research Associate II, execute routine Quality Control (QC) testing activities as assigned. Support CAPAs, change controls, investigations, and deviations; participate in development and validation of analytical methods for the Analytical Development group. Assist with testing, project support, data review, ordering laboratory supplies, and laboratory upkeep.

• Support QC analytical chemistry testing using HPLC, UPLC, GC, KF, dissolution, and other instrumentation.
• Author technical reports as required.
• Ensure instrument calibration and qualification are up to date.
• Troubleshoot instrumentation issues and coordinate vendor repairs.
• Coordinate with Supervisor on scheduling testing for reagents and product samples.
• Participate in data review.
• Participate in method development and validation.
• Coordinate external outsourcing of testing.
• Support CAPAs, change controls, investigations, and deviations; ensure timely closure with Quality Assurance.
• Follow Good Documentation Practices (GDP) and maintain contemporaneous records/logbooks/forms.
• Adhere to cGMPs at all times.

• Bachelor’s degree in Chemistry or related field.
• 2+ years of experience in a GMP Quality Control environment.
• Prior experience with HPLC and UPLC.

• Knowledge of CFR 210, 211, USP, and FDA/ICH guidance.
• Experience with USP App IV dissolution apparatus.

• Knowledge of safe laboratory practices.
• Strong verbal and written communication.

Mix of office and laboratory environments; must be able to work in chemical laboratory environments.