Quality Assurance Specialist – On the Floor

About the role

We are seeking a 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. PBF is a one-of-a-kind cGMP-compliant pharmaceutical manufacturing facility engaging in next-generation development for cutting-edge companies and government agencies. The professionals at PBF are engaging in trailblazing endeavors every day. Most exciting, the end products vary, so every year brings multiple opportunities for professional enrichment in original projects.

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.
• 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.
• Support 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.
• 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 4 years of relevant experience.
• Demonstrated 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.

Physical Requirements, Workplace Hazards & Conditions, and PPE/Chemical Requirements

• Constantly required to perform sedentary work that primarily involves sitting/standing.
• Occasionally required to perform light work that includes moving objects up to 20 pounds.
• Occasionally required to push or pull less than 25 pounds, push or pull 25–45 pounds, and reach above shoulder level.
• Rarely required to push or pull more than 45 pounds.
• Occasionally required to reach above shoulder level.
• Constantly required to use both hands.
• Occasionally required to stand or walk for more than 25 minutes, and bend, reach, or twist repeatedly.
• Occasionally required to kneel, squat, or stoop, and crawl or climb.
• Constantly required to have clear vision (near and/or far), depth perception, peripheral vision, and/or visual acuity.
• Occasionally required to ascend or descend ladders, stairs, scaffolding, ramps, poles, and the like; move self in different positions to accomplish tasks in various environments including tight and confined spaces; and move about to accomplish tasks or move from one worksite to another.
• Constantly required to communicate with others to exchange information.
• Rarely required to operate machinery and/or power tools, and operate motor vehicles or heavy equipment.
• Constantly required to assess the accuracy, neatness, and thoroughness of the work assigned.
• Occasionally required to work in low temperatures, high temperatures, outdoor elements such as precipitation and wind, in noisy environments, in hazardous conditions, poor ventilation, and in small and/or enclosed spaces.
• Occasionally required to work where no adverse environmental conditions are expected.
• Occasionally required to wear PPE including but not limited to gloves, face shields/goggles, safety glasses, safety shoes, lab coat, and ear plugs/muffs.
• Constantly required to wear a clean room uniform.
• Occasionally required to wear disposable dust/surgical mask, and wear respirators such as a disposable respirator mask (N-95), half-face/full-face style, PAPR, SCUBA.
• Occasionally will come in contact with chemicals such as aerosols, biological inhalants, plastics, inorganic dust, and powders.

Benefits

• Medical, dental, and vision insurance for individuals and families
• FSAs and HSA
• Life and AD&D insurance
• Short- and long-term disability
• Legal services
• Voluntary hospital indemnity, critical illness, and accident insurances
• Employee Assistance Program (EAP)
• Pet insurance
• 401(k) with employer match and Roth option
• Tuition and professional reimbursement
• Public transportation support in the DMV area
• Referral bonus program
• Vacation with tenure-based increases
• PTO
• 11 paid holidays
• Paid bonding leave
• Paid supplemental short-term disability