Job Description

Position Summary :

Execute routine quality control testing activities as assigned by management. Support CAPA’s, change controls, investigations, and deviations. Participate in the development and validation of analytical methods for Analytical Development group. Participate in testing, project support, data review, ordering of laboratory supplies, and general upkeep of the laboratory.

Principal Duties and Responsibilities include the following :

• 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.
• Coordinate with supervisor on scheduling of testing for reagents and product samples.
• Participate in data review.
• Participate in method development and validation activities
• Coordinate 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 (maintaining contemporaneous records, filling out logbooks, forms, etc.)
• Adherence to cGMPs at all times.

Qualification Requirements :

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

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