On-the-Floor QA Specialist – Pilot Bioproduction

CAMRIS International; Silver Spring (MD); On-site; USD 95,000 - 125,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) with employer match

Job summary

CAMRIS International seeks an experienced QA Specialist - On the Floor at its Pilot Bioproduction Facility in Silver Spring, MD. The role ensures early-phase manufacturing activities comply with cGMP, internal procedures, and regulatory requirements while supporting scale-up and process development.

You will monitor production on the floor, review batch records, manage deviations and CAPAs, and collaborate with Manufacturing, Process Development, QC, and Engineering to enable agile, compliant

Qualifications

• Bachelor's degree in Biology, Microbiology, Biochemistry, Pharmaceutical Sciences, or related field with 4 years of relevant GMP experience.
• QA experience in a GMP-regulated pharmaceutical, biologics, or vaccine manufacturing environment.
• Strong knowledge of cGMP regulations, aseptic processing, and regulatory expectations (FDA, EMA, ICH).
• Experience providing on-the-floor QA support in a manufacturing environment.
• Proven experience with batch record review, deviation investigations, and CAPA management.
• Ability to assess quality risks and make sound real-time decisions.
• Attention to detail, technical writing, and documentation skills.
• Effective cross-functional communication and collaboration.

Responsibilities

• Provide direct QA support during pilot-scale manufacturing operations and process development activities.
• Perform real-time batch record review to ensure GMP compliance.
• Monitor aseptic practices and operator techniques in a dynamic environment.
• Ensure proper line clearance, equipment setup verification, and status labeling.
• Review and approve GMP documentation including batch records, logs, and reports.
• Identify deviations, non-conformances, and compliance risks; support CAPA and investigations.
• Maintain ALCOA+ data integrity across development and GMP docs.
• Participate in change control, deviation management, CAPA, and audit readiness activities.

Skills

On-floor QA support

cGMP knowledge

Regulatory awareness

Documentation

CAPA management

Cross-functional collaboration

Risk assessment

Education

Bachelor's degree in Biology/GBMP related

Tools

TrackWise

Veeva

Job description

CAMRIS International seeks an experienced QA Specialist - On the Floor at its Pilot Bioproduction Facility in Silver Spring, MD. The role ensures early-phase manufacturing activities comply with cGMP, internal procedures, and regulatory requirements while supporting scale-up and process development.

You will monitor production on the floor, review batch records, manage deviations and CAPAs, and collaborate with Manufacturing, Process Development, QC, and Engineering to enable agile, compliant