Senior Quality Assurance Specialist – On the Floor

Overview

We are seeking a Senior Quality Assurance (QA) Specialist - On the Floor to support the Pilot Bioproduction Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland. This role ensures that early-phase (Phase I/II) clinical, pilot-scale, and process development manufacturing activities comply with current Good Manufacturing Practices (cGMP), internal procedures, and regulatory requirements. This position operates in a dynamic environment where processes may be evolving, and scale-up activities are ongoing. The Senior QA Specialist serves as a critical partner to Manufacturing, Process Development, Quality Control, and Engineering teams by actively monitoring operations on the production floor, identifying risks, and ensuring quality and compliance standards are upheld while enabling agility and innovation.

Responsibilities

• Provide direct QA support during pilot-scale manufacturing operations, including process development, technology transfer, scale-up, and clinical production activities.
• Perform real-time batch record review (including development and engineering batches) to ensure accuracy, completeness, and compliance with GMP expectations.
• Monitor critical processes, aseptic practices, and operator techniques in a flexible, evolving manufacturing environment.
• Ensure proper line clearance, equipment setup verification, and status labeling across multi-product or campaign-based operations.
• Review and approve GMP documentation including executed batch records, logbooks, protocols, and reports.
• Identify, document, and escalate deviations, non-conformances, and compliance risks in a fast-paced pilot environment.
• Lead or support investigations, root cause analysis, and implementation of corrective and preventive actions (CAPAs), with emphasis on continuous improvement.
• Ensure data integrity principles (ALCOA+) are maintained across both development and GMP documentation.
• Participate in change control, deviation management, CAPA, and audit readiness activities, particularly for new or evolving processes.
• Support internal audits, regulatory inspections, and client audits, including readiness for early-phase (Phase I/II) GMP manufacturing.
• Ensure compliance with regulatory requirements (FDA, EMA, ICH guidelines) while supporting innovation and speed.
• Support electronic documentation management system administration and use as required.
• Partner closely with Manufacturing, Process Development, Quality Control, Validation, and Engineering teams to ensure seamless execution of pilot operations.
• Provide QA oversight for new process implementation, ensuring appropriate documentation, risk assessments, and controls are in place.
• Support development of batch records, SOPs, and control strategies for new or modified processes.
• Mentor other QA staff and assist in training personnel on GMP expectations in a development-stage environment.
• Perform other duties as assigned in support of quality and operational objectives.

Qualifications

• Bachelor's degree in Biology, Microbiology, Biochemistry, Pharmaceutical Sciences, or related field and 10 years of relevant experience.
• 4-7+ years of QA experience in a GMP-regulated pharmaceutical, biologics, or vaccine manufacturing environment.
• Strong working knowledge of cGMP regulations, aseptic processing, and regulatory expectations (FDA, EMA, ICH).
• Demonstrated experience providing on-the-floor QA support in a manufacturing environment.
• Proven experience with batch record review, deviation investigations, and CAPA management.
• Ability to independently assess quality risks and make sound decisions in real time.
• Strong attention to detail, technical writing, and documentation skills.
• Effective communication skills with the ability to influence cross-functional teams.
• Experience supporting regulatory inspections (e.g., FDA, EMA).
• Knowledge of quality systems such as TrackWise, Veeva, or similar platforms.
• Must be currently eligible to work in the United States without visa sponsorship and have lived in the United States for three of the past five years if a non-US citizen.
• A REAL ID or U.S. passport is required for WRAIR base access.