QA Specialist I – GMP/GDP Data Review & Compliance

Goodwin-Biotechnolog; Plantation (FL); On-site; USD 90,000 - 120,000; Full time

Job summary

Goodwin-Biotechnolog is seeking a Quality Control / QA Review professional to ensure GMP/GDP compliance and accurate batch disposition. You will review manufacturing and QC data, deviations, CAPAs, and change controls, while supporting audits and regulatory inspections.

The role requires experience with eQMS, LIMS, electronic batch records, and audit trails, plus strong attention to detail and cross-functional collaboration across manufacturing and QC teams.

Qualifications

• Experience in a biologics CDMO or clinical-phase drug substance and/or sterile drug product manufacturing environment.
• Familiarity with batch disposition packages, aseptic processing, environmental monitoring, OOS/OOT investigations, deviations, CAPAs and change controls.
• Experience with electronic quality management systems (eQMS), laboratory information management systems (LIMS), electronic batch records and audit trail review.
• Excellent written and verbal communication skills with the ability to effectively promote intra-and inter-departmental cooperation.
• High attention to detail
• Knowledge of GMP, ICH and compendial requirements and their application.

Responsibilities

• Review batch records and records for completeness, contemporaneous documentation, adherence to instructions, critical process parameters, calculations, yields, material reconciliation and traceability.
• Ensure QC documents comply with GMP and GDP.
• Review records related to deviations, change controls, OOS and CAPAs.
• Assist in Client/Regulatory audits and regulatory inspections.
• Monitor notebooks to ensure timely issuance, review, and archival.

Skills

Biologics CDMO

Aseptic processing

Environmental monitoring

OOS/OOT investigations

Deviations

CAPA

Change controls

eQMS

LIMS

Electronic batch records

Audit trails

GMP/ICH knowledge

Attention to detail

Communication skills

Job description

Goodwin-Biotechnolog is seeking a Quality Control / QA Review professional to ensure GMP/GDP compliance and accurate batch disposition. You will review manufacturing and QC data, deviations, CAPAs, and change controls, while supporting audits and regulatory inspections.

The role requires experience with eQMS, LIMS, electronic batch records, and audit trails, plus strong attention to detail and cross-functional collaboration across manufacturing and QC teams.