On-the-Floor QA Lead — Pilot Bioproduction (GMP/FDA)

CAMRIS International; Silver Spring (MD); On-site; USD 110,000 - 160,000; Full time

Job summary

CAMRIS International seeks a Senior QA Specialist on the floor to oversee pilot bioproduction operations at WRAIR in Silver Spring, MD. You will monitor aseptic processes, review batch records, and drive CAPAs to ensure Phase I/II manufacturing meets cGMP and regulatory standards.

In this role, you will collaborate with Manufacturing, Process Development, QA Control, Validation, and Engineering to enable agile, compliant production and rapid issue resolution on evolving workflows.

Qualifications

• Bachelor's degree in Biology, Microbiology, Biochemistry, Pharmaceutical Sciences, or related field; 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 on-the-floor QA support in a manufacturing environment.
• Experience with batch record review, deviation investigations, and CAPA management.
• Ability to assess quality risks and make real-time decisions.
• Excellent attention to detail, writing, and documentation skills.
• Effective cross-functional communication to influence teams.
• Experience supporting regulatory inspections (FDA, EMA).
• Knowledge of QA systems such as TrackWise, Veeva, or similar platforms.
• Eligible to work in the United States without visa sponsorship; capable of base access.

Responsibilities

• Provide direct QA support during pilot-scale manufacturing operations, including process development and scale-up.
• Perform real-time batch record review to ensure accuracy, completeness, and GMP compliance.
• Monitor critical processes, aseptic practices, and operator techniques in a dynamic environment.
• Ensure line clearance, equipment setup verification, and status labeling across multi-product operations.
• Review and approve GMP documentation, including batch records, logs, protocols, and reports.
• Identify, document, and escalate deviations, non-conformances, and risks.
• Lead or support investigations and CAPA with focus on continuous improvement.
• Maintain ALCOA+ data integrity across development and GMP documentation.
• Participate in change control, deviation management, and audit readiness activities.
• Support internal/regulatory inspections and client audits for Phase I/II GMP manufacturing readiness.
• Collaborate with Manufacturing, Process Development, QA, Validation, and Engineering for seamless pilot operations.
• Provide QA oversight for new process implementations with proper documentation and risk assessments.
• Assist in developing batch records, SOPs, and control strategies for new/modified processes.
• Mentor QA staff and train personnel on GMP expectations in a development-stage environment.
• Perform other duties to support quality and operations objectives.

Skills

QA on-floor

cGMP knowledge

Documentation skills

Regulatory inspections

Problem solving

Education

Bachelor's degree in Biology or related

Tools

TrackWise

Veeva

Job description

CAMRIS International seeks a Senior QA Specialist on the floor to oversee pilot bioproduction operations at WRAIR in Silver Spring, MD. You will monitor aseptic processes, review batch records, and drive CAPAs to ensure Phase I/II manufacturing meets cGMP and regulatory standards.

In this role, you will collaborate with Manufacturing, Process Development, QA Control, Validation, and Engineering to enable agile, compliant production and rapid issue resolution on evolving workflows.