Sr Research Associate II

Job Responsibilities:

• Reviews cGMP data generated during testing to support product release, stability and facilities monitoring using HPLC, UPLC, Capillary Electrophoresis and wet chemistry methods. Ensures that standards for documentation and comply with SOPs (analytical methods and Good Documentation Practices) and industry standards.
• Strong technical knowledge including an understanding of laboratory procedures, methodology and standards.
• Review laboratory logbooks, labeling and other documentation to ensure conformations with SOPs and industry guidelines.
• Provides technical support for monitoring and evaluating the performance of analytical methods to demonstrate ongoing method suitability.
• Compile and summarize QC raw data in various physical and electronic report formats.
• Reviews raw data, protocols, reports and certificates of analysis.
• Provides guidance and training to QC personnel to support company training in the procedures used to effectively execute testing.
• Participates in compliance-focused teams working towards the goal of continuous improvement of laboratory documentation practices.
• May coordinate and track progress of analytical testing internally or at CROs.
• May participate in regulatory agency audits and inspections

Specific Education & Experience Requirements:
7+ years of experience with AA degree
5+ years of experience with BS degree in a relevant scientific discipline.
3+ years of experience with MS degree in a relevant scientific discipline.


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