CONTRACT PHARMACAL

About CONTRACT PHARMACAL

Description: Position Summary: The QC Stability Lab Technician has the primary responsibility for assisting stability manager or designee to manage the stability program and producing product stability summary reports in support of product expiry. Responsibilities: Responsibilities include, but are not limited to: Update stability sample calendar as required. Track samples placed in the stability chambers. Review created labels for stability samples as per schedule. Perform sample pulls and track testing status. Write and update stability summary reports. Assist manager or designee to prepare stability summary reports to provide for customers and for APR reports. Monitor retain samples in stability room storage area. Monitor stability chambers and the stability room and assure units are operational. Performs Stability Disintegration & Weight Variation testing. Update the following Microsoft Access Databases: 1. Stability Sample Receiving and Analysis program 2. Stability Room Retain Sample program 3. OTC Database (Stability Calendar) Other responsibilities as assigned by Senior Quality Management. Requirements: Education and Experience: Bachelor’s degree and at least 4 years work experience in Pharmaceutical Stability and QA. Skills and Abilities: Knowledge of cGMPs related to US FDA manufacturing environments Knowledge of Quality System requirements Knowledge of ICH and USP requirements

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Company Info

Legal Form: CORP

Company Type: Private

Company Size: 501 - 1000

Revenue: 100 - 500 million (USD)

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