Senior Quality Assurance Specialist

Senior Quality Assurance Specialist - Validation

Hunter Healthcare are currently exclusively supporting a speciality pharmaceutical company with a Senior Quality Assurance Specialist - Validation position.

As the organisation continues to scale, they are seeking experienced a QA professional to play a key role in maintaining and enhancing quality systems, ensuring the highest standards of compliance across operations.

This role will be onsite, with the office being based in Northern California.

Key Responsibilities

• Review and approve validation protocols, including Process Validation, Cleaning Validation, and Equipment Validation documentation.
• Review and approve Computer System Validation (CSV) documentation to ensure compliance with regulatory and quality requirements.
• Review and approve Validation Master Plans (VMPs), risk assessments, and validation summary reports.
• Lead and support investigations into validation failures, identify root causes, and implement effective Corrective and Preventive Actions (CAPAs) to prevent recurrence.

Qualifications

• Bachelor’s degree in a scientific or related discipline.
• Proven experience working within FDA / cGMP-regulated environments.
• Strong knowledge of FDA Process Validation guidance.
• Background in sterile or aseptic manufacturing environments is highly desirable.

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