QA Auditor - (US-NY-Pearl River - 10965)

Minimum Education: None
Jobcode: sunnj3714NY_QAAuditor_TK
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1) Independently leads the QA input to validation projects in support of commercial manufacturing.
2) Review/Audit batch records. Provides input into strategy and direction to project teams on compliance/technical issues related to validation efforts to achieve compliance with company policies and government regulations.

Reviews and approves validation documentation including specifications, protocols and reports with a focus on cGMP impact and validation lifecycle requirements.

Independently reviews commissioning and validation documentation for compliance with company policies and government regulations.

Document approval including specifications, protocols and reports with a focus on cGMP impact and validation lifecycle requirements. Participates on validation project teams and provides guidance and direction from a regulatory compliance perspective.

Actively and independently steer project teams to meet company policies and government regulations.

B.S with 5+ years related experience in pharma/biotech required.

Expertise in Quality Assurance batch record auditing, compliance or validation.