Pharma Quality & Validation Specialist

Phlow Corp; Petersburg (VA); On-site; USD 60,000 - 70,000; Full time

Job summary

Phlow Corp in Petersburg, VA, is seeking a Pharmaceutical Quality Specialist to oversee documentation and qualification activities for pharmaceutical manufacturing. The role ensures compliance with FDA, EMA, and cGMP standards, maintaining product integrity and patient safety.

You will author and review procedures, support audits, manage validation documentation (IQ/OQ/PQ), and drive continuous improvement with cross-functional teams.

Qualifications

• Minimum 5 years in a pharmaceutical/biotech setting.
• Strong knowledge of FDA, ICH, cGMP, and GAMP5.
• Hands-on qualification and validation experience for processes, facilities, equipment, utilities, and computerized systems.
• Excellent communication, problem-solving, and organizational skills.

Responsibilities

• Author, review and approve procedures, reports, batch records and other documents for manufacturing processes.
• Oversee Quality Operations including batch record reviews, deviations, and CAPA actions.
• Support calibration/maintenance programs and ensure GMP compliance.
• Lead quality risk analyses and quality-based training of operations staff.
• Support internal/external audits, inspections, and regulatory submissions.

Skills

Quality Assurance

GMP

Documentation management

Regulatory compliance

Quality systems

Validation

Education

Bachelor's degree (Science/Engineering/Pharmacy)

Tools

QMS software

ERP software

Documentation management systems

Job description

Phlow Corp in Petersburg, VA, is seeking a Pharmaceutical Quality Specialist to oversee documentation and qualification activities for pharmaceutical manufacturing. The role ensures compliance with FDA, EMA, and cGMP standards, maintaining product integrity and patient safety.

You will author and review procedures, support audits, manage validation documentation (IQ/OQ/PQ), and drive continuous improvement with cross-functional teams.