Senior Quality Assurance Specialist – On the Floor

CAMRIS•Silver Spring, MD

11d•Onsite

About The Position

The Senior 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. In a dynamic environment with evolving processes and ongoing scale-up, the specialist partners with Manufacturing, Process Development, Quality Control, and Engineering teams. The role involves active oversight of production-floor operations, identifying risks, and upholding quality and compliance standards while supporting agility and innovation. The facility conducts cGMP pharmaceutical manufacturing and development work for companies and government agencies, with varied projects offering opportunities to work on different products and processes. The position requires a bachelor's degree in a related scientific field and substantial relevant experience, including QA experience in GMP-regulated pharmaceutical, biologics, or vaccine manufacturing. Employment is contingent on successful completion of a secret-level background check for an active federal contract. 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. The role involves frequent clean-room uniform use and may require PPE and work in varied environmental conditions, including hazardous, noisy, temperature-extreme, or confined environments. Physical activities and requirements are detailed in the posting.

Requirements

Bachelor's degree in Biology, Microbiology, Biochemistry, Pharmaceutical Sciences, or a 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 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 the secret-level background check required under the active federal contract.
Must be able to meet the physical, workplace, PPE, and chemical requirements described in the posting; reasonable accommodation may be provided.

Responsibilities

Provide direct QA support during pilot-scale manufacturing operations, 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 proper line clearance, equipment setup verification, and status labeling in 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.
Lead or support investigations, root cause analysis, and 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 administration and use of the electronic documentation management system as required.
Partner with Manufacturing, Process Development, Quality Control, Validation, and Engineering teams to ensure effective pilot operations.
Provide QA oversight for new process implementation, ensuring appropriate documentation, risk assessments, and controls.
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.