On-the-Floor QA Specialist – Pilot Bioproduction

CAMRIS International, LLC; Silver Spring (MD); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Comprehensive benefits package

401(k) with employer match

Public transportation support

Job summary

CAMRIS International, LLC is seeking a Quality Assurance (QA) Specialist - On the Floor to support the Pilot Bioproduction Facility at WRAIR in Silver Spring, MD. The role ensures early-phase manufacturing activities comply with cGMP, internal procedures, and regulatory requirements while collaborating with Manufacturing, Process Development, Quality Control, and Engineering teams.

The successful candidate will monitor operations on the production floor, identify risks, review GMP documentation,

Qualifications

• GMP-regulated QA experience in pharma, biologics, or vaccine manufacturing.
• Strong knowledge of cGMP regulations, aseptic processing, and regulatory expectations (FDA, EMA, ICH).
• Experience on-the-floor QA support in a manufacturing environment.
• Batch record review, deviation investigations, and CAPA management experience.
• Ability to assess quality risks and make real-time decisions.
• Attention to detail, technical writing, and documentation skills.
• Experience supporting regulatory inspections (FDA/EMA).
• Knowledge of quality systems such as TrackWise, Veeva, or similar platforms.

Responsibilities

• Provide direct QA support during pilot-scale manufacturing operations, including process development and scale-up.
• Perform real-time batch record review for accuracy and compliance with GMP.
• Monitor aseptic practices and operator techniques in a dynamic environment.
• Ensure line clearance, equipment setup verification, and labeling across campaigns.
• Review and approve GMP documents including batch records, logbooks, protocols, and reports.
• Identify and elevate deviations and compliance risks in a fast-paced pilot setting.
• Support investigations, root-cause analysis, and CAPA implementations.

Skills

QA on the floor

GMP knowledge

Batch record review

CAPA management

Cross‑functional communication

Regulatory inspections support

FDA/EMA awareness

Document control

Education

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

Tools

TrackWise

Veeva

Job description

CAMRIS International, LLC is seeking a Quality Assurance (QA) Specialist - On the Floor to support the Pilot Bioproduction Facility at WRAIR in Silver Spring, MD. The role ensures early-phase manufacturing activities comply with cGMP, internal procedures, and regulatory requirements while collaborating with Manufacturing, Process Development, Quality Control, and Engineering teams.

The successful candidate will monitor operations on the production floor, identify risks, review GMP documentation,