Quality Control Specialist -WYETH-USA- Pearl River, NY

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Having reached a high level of technical expertise, works independently with QC staff to validate QC instrumentation. Reviews and approves documentation including specifications, standard operating procedures, protocols and reports. Provides independent QC input to projects in support of commercial or clinical manufacturing. Administers change control activities for QC laboratory instruments and leads annual re-qualifications. Provides direction to project teams on compliance/technical issues related to efforts to achieve compliance with company policies and government regulations. Independently troubleshoots problems and resolves issues regarding instrument validation.

Job Responsibilities

*Qualifies QC laboratory instrumentation and validates laboratory computerized systems.

*Performs system administration functions for laboratory benchtop computerized systems.

*Generates and reviews documentation for compliance with company policies and government regulations.

*Participates on project teams and provides guidance and direction from a regulatory compliance perspective.

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