Pharmaceutical Quality & Validation Specialist

Socket.dev; Petersburg (VA); On-site; USD 60,000 - 70,000; Full time

Job summary

Phlow is seeking a Pharmaceutical Quality Specialist to oversee documentation and processes essential for qualification activities in pharmaceutical manufacturing. You will ensure compliance with FDA, EMA, and cGMP standards and maintain product integrity and patient safety.

This role leads quality operations, validation management, and documentation control, and collaborates with Manufacturing, Engineering, and Regulatory Affairs to drive continuous improvement and regulatory readiness.

Qualifications

• Minimum 5 years in a pharmaceutical or biotech environment.
• Strong knowledge of FDA, ICH and other global regulatory requirements, including cGMP and GAMP5.
• Hands-on experience with qualification and validation of processes, facilities, equipment, utilities, and computerized systems.
• Proficiency with QMS and ERP documentation systems is a plus.

Responsibilities

• Author, review and approve procedures, reports, batch records and other documents to support ongoing manufacturing processes.
• Oversee quality operations including real-time batch record review, deviations, and CAPA.
• Provide quality review and support for calibration and maintenance programs per GMP.
• Lead quality risk analyses and quality-based training of operations staff.
• Support quality processes across the product lifecycle including change control, deviations and investigations.

Skills

GMP knowledge

Documentation management

Validation management

Quality systems

Regulatory compliance

Audit support

Education

Bachelor’s degree in Science, Engineering, Pharmacy, or related field

Tools

QMS software

ERP software

Job description

Phlow is seeking a Pharmaceutical Quality Specialist to oversee documentation and processes essential for qualification activities in pharmaceutical manufacturing. You will ensure compliance with FDA, EMA, and cGMP standards and maintain product integrity and patient safety.

This role leads quality operations, validation management, and documentation control, and collaborates with Manufacturing, Engineering, and Regulatory Affairs to drive continuous improvement and regulatory readiness.