Quality Assurance Documentation & Compliance Specialist

GBI Bio; Plantation (FL); On-site; USD 75,000 - 110,000; Full time

Job summary

GBI Bio seeks an experienced Quality Controls Documentation Reviewer to ensure the integrity of analytical and manufacturing records within a biologics environment.

You will review batch records, SOPs, and reports to support compliant disposition and regulatory readiness, uphold GDP/21CFR210/211 standards, and coordinate with QA/QC teams. Strong attention to detail and clear communication are essential for success.

Qualifications

• Experience in biologics CDMO or clinical-stage drug substances and sterile manufacturing.
• Familiar with batch disposition packages, aseptic processing, environmental monitoring, deviations, CAPAs and change controls.
• Experience with electronic quality management systems (eQMS) and LIMS, electronic batch records and audit trail review.
• Excellent written and verbal communication; detail-oriented; GMP/ICH knowledge.

Responsibilities

• Review analytical testing and manufacturing documents for timely compliant disposition.
• Review manufacturing and QC data for GDP and data verification per 21CFR210/211.
• Originate or review exception documents (OOS, OOT, deviations, CAPA, Change Control).
• Review in-process test results and master filling records.
• Review microbiology data for release of raw materials and final product.
• Assist during client/regulatory audits and inspections.
• Monitor notebooks to ensure timely issuance, review, and archival per standards.
• Verify equipment calibration, maintenance, qualification and cleaning records in batch reviews.

Skills

Biologics CDMO experience

Aseptic processing

OOS investigations

eQMS experience

LIMS experience

Electronic batch records

Audit trail review

Communication skills

Attention to detail

GMP/ICH knowledge

Job description

GBI Bio seeks an experienced Quality Controls Documentation Reviewer to ensure the integrity of analytical and manufacturing records within a biologics environment.

You will review batch records, SOPs, and reports to support compliant disposition and regulatory readiness, uphold GDP/21CFR210/211 standards, and coordinate with QA/QC teams. Strong attention to detail and clear communication are essential for success.