Quality Assurance Specialist – On the Floor

CAMRIS•Silver Spring, MD

1d•Onsite

About The Position

The Quality Assurance Specialist – On the Floor supports the Pilot Bioproduction Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland. The 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. Working in a dynamic environment with evolving processes and ongoing scale-up, the specialist partners with Manufacturing, Process Development, Quality Control, Validation, and Engineering teams. The role provides active quality oversight on the production floor, identifies risks, and upholds quality and compliance standards while supporting innovation and operational agility. The facility conducts cGMP pharmaceutical manufacturing and development work for companies and government agencies. The position requires a bachelor's degree in a related life-sciences or pharmaceutical field and four years of relevant experience. Candidates must be eligible to work in the United States without visa sponsorship and, if a non-U.S. citizen, must have lived in the United States for three of the past five years. A REAL ID or U.S. passport is required for WRAIR base access. Employment is contingent on successful completion of a secret-level background check under an active federal contract.

Requirements

Bachelor's degree in Biology, Microbiology, Biochemistry, Pharmaceutical Sciences, or a related field, and four 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 FDA, EMA, and ICH regulatory expectations.
Demonstrated experience providing on-the-floor QA support in a manufacturing environment.
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 and ability to influence cross-functional teams.
Experience supporting regulatory inspections, such as FDA or EMA inspections.
Knowledge of quality systems such as TrackWise, Veeva, or similar platforms.
Must be eligible to work in the United States without visa sponsorship.
If a non-U.S. citizen, must have lived in the United States for three of the past five years.
A REAL ID or U.S. passport is required for WRAIR base access.
Must successfully complete a secret-level background check for the active federal contract.
Must be able to meet the described physical, workplace, PPE, and chemical-contact requirements, with reasonable accommodation available where applicable.

Responsibilities

Provide direct QA support during pilot-scale manufacturing, including process development, technology transfer, scale-up, and clinical production.
Perform real-time batch record review, including development and engineering batches, for accuracy, completeness, and GMP compliance.
Monitor critical processes, aseptic practices, and operator techniques in an evolving manufacturing environment.
Ensure 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.
Support investigations, root cause analysis, and implementation of corrective and preventive actions (CAPAs), emphasizing continuous improvement.
Maintain data integrity principles (ALCOA+) across 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 GMP manufacturing.
Ensure compliance with FDA, EMA, and ICH requirements while supporting innovation and speed.
Support electronic documentation management system administration and use as required.
Partner with Manufacturing, Process Development, Quality Control, Validation, and Engineering teams to support pilot operations.
Support new process implementation, including appropriate documentation, risk assessments, and controls.
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.