On-the-Floor QA Lead - GMP Pilot Manufacturing

CAMRIS International, LLC; Silver Spring (MD); Presencial; USD 110 000 - 150 000; Tempo integral

Resumo da oferta

CAMRIS International, LLC is seeking a Senior QA Specialist - On the Floor to support the Pilot Bioproduction Facility (PBF) at WRAIR in Silver Spring, MD. This role ensures early-phase clinical and pilot-scale manufacturing comply with cGMP, internal procedures, and regulatory requirements.

The Senior QA Specialist collaborates with Manufacturing, Process Development, QC, and Engineering teams to monitor operations on the production floor, identify risks, and uphold quality while enabling

Qualificações

• Bachelor's degree in Biology, Microbiology, Biochemistry, Pharmaceutical Sciences, or related field; 10 years of relevant experience.
• 4–7+ years of QA experience in GMP-regulated pharmaceutical manufacturing environments.
• Strong knowledge of cGMP, aseptic processing, and regulatory expectations (FDA, EMA, ICH).
• Experience providing on-the-floor QA support in manufacturing environments.
• Proven ability to review batch records, lead deviation investigations, and manage CAPAs.
• Ability to assess quality risks and make timely decisions; attention to detail and solid documentation skills.

Responsabilidades

• Provide direct QA support during pilot-scale operations, technology transfer, scale-up, and clinical production.
• Perform real-time batch record reviews to ensure accuracy, completeness, and GMP compliance.
• Monitor aseptic processes and operator techniques in a dynamic manufacturing setting.
• Ensure proper line clearance, equipment setup verification, and status labeling across campaigns.
• Review and approve GMP documentation including batch records, logbooks, protocols, and reports.
• Elevate deviations, non-conformances, and risks; lead investigations and CAPA implementation.
• Maintain ALCOA+ data integrity across development and GMP documentation.
• Support change control, deviation management, and audit readiness activities for new processes.
• Assist in internal audits, regulatory inspections, and readiness for Phase I/II GMP manufacturing.
• Ensure compliance with FDA, EMA, ICH guidelines while enabling innovation and speed.
• Participate in electronic documentation management system administration as required.
• Collaborate with Manufacturing, Process Development, QC, Validation, and Engineering for seamless pilot operations.

Conhecimentos

On-the-floor QA

cGMP knowledge

Batch record review

Deviation investigations

CAPA management

ALCOA+ data integrity

Regulatory inspections

TrackWise/Veeva knowledge

Cross-functional collaboration

Technical writing

Formação académica

Bachelor's degree in Biology, Microbiology, Biochemistry, Pharmaceutical Sciences, or related field

Ferramentas

TrackWise

Veeva

Descrição da oferta de emprego

CAMRIS International, LLC is seeking a Senior QA Specialist - On the Floor to support the Pilot Bioproduction Facility (PBF) at WRAIR in Silver Spring, MD. This role ensures early-phase clinical and pilot-scale manufacturing comply with cGMP, internal procedures, and regulatory requirements.

The Senior QA Specialist collaborates with Manufacturing, Process Development, QC, and Engineering teams to monitor operations on the production floor, identify risks, and uphold quality while enabling