Our client is seeking a QAV Specialist to support validation of analytical methods for their QC labs. The ideal candidate would have QA experience on the manufacturing side and have experience with HPLC and wet chemistry. The client prefers candidates from the local area who could come onsite 2 days per week.
• Provide quality oversight to Analytical instruments and related computers systems validation activities in alignment with the Analytical Instrument Qualification and Computer System Validation lifecycle process.
• Provide quality oversight to ensure implementation of data integrity controls and data lifecycle mapping (including approval of documents establishing equipment specific period review, backup/restore, and audit trail activities) associated with projects.
• Provide technical assessments on change controls, assessing proposed changes to validated processes to identify requirements necessary to maintain validated status.
• Own execution and implementation phase quality activities for change controls related to projects, while supporting quality FTE pre and post approvals of change controls.
• Demonstrated PM skills
• Represent the QA-Validation team on project core teams and participate in strategy discussions aligned with global initiatives and regulatory requirements.
• Communicate future needs for method validation for applicable systems to internal QA method validation team.
Lexington MA: QAV Specialist (231997)