Note: The job is a remote job and is open to candidates in USA. JCW Group is recruiting for an unnamed client seeking a Senior QA Consultant to provide broad quality assurance support in a pharmaceutical environment. The role is primarily GMP-focused, with some exposure to GCP and clinical activities.

Responsibilities

• Batch record review and product disposition/release
• Temperature excursion and GDP-related activities
• Deviations, CAPAs, change controls, and general QA support
• Review of regulatory filings, INDs, clinical protocols, and related documentation
• Partner with cross-functional teams to follow up on open quality items and keep projects moving
• Jump into various QA activities as priorities shift

Skills

• 12+ years of pharmaceutical/biotech QA experience
• Strong GMP background with hands-on QA experience
• Experience with batch review/release and quality systems
• Self-starter who is comfortable working independently and taking ownership
• Strong communication and follow-up skills
• Must be comfortable working EST
• GCP, clinical, or regulatory experience is a plus

Benefits

• Remote

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