Pharma Quality & Compliance Specialist

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

Benefits offered by this job

Medical insurance

Stock options

Paid time off

Job summary

Phlow is seeking a Pharmaceutical Quality Specialist to oversee documentation and processes essential for qualification activities in pharmaceutical manufacturing and quality operations. This role ensures compliance with FDA, ICH and cGMP standards, leads validation activities (IQ/OQ/PQ) and audits, and partners with cross‑functional teams to drive process improvements and product integrity.

Strong communication and organizational skills are required to succeed in a fast-paced environment and to

Qualifications

• Minimum 5 years of experience in a pharmaceutical or biotechnology 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.
• Excellent communication, problem-solving, and organizational skills.

Responsibilities

• Author, review and/or approve procedures, reports, batch records and other necessary documents to support ongoing manufacturing processes that follow regulatory standards.
• Responsible for Quality Operations oversight including real-time batch record review, response to deviations and implementation of corrective actions.
• Lead quality risk analysis and provide quality review and support for calibration and maintenance programs.
• Support quality processes and systems across the product lifecycle including change control, CAPA, deviations and investigations, label control, laboratory control and management escalation.
• Lead validation documentation lifecycle for equipment, processes, facilities, and computer systems in the pharmaceutical environment.

Skills

Regulatory knowledge

Quality assurance

Communication

Problem-solving

Organizational skills

Education

Bachelor's degree in Science/Engineering/Pharmacy

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 and quality operations. This role ensures compliance with FDA, ICH and cGMP standards, leads validation activities (IQ/OQ/PQ) and audits, and partners with cross‑functional teams to drive process improvements and product integrity.

Strong communication and organizational skills are required to succeed in a fast-paced environment and to