QA Specialist I

Goodwin Biotechnology Inc•Plantation, FL

About The Position

The QA Specialist I reviews analytical testing and manufacturing documents and records to support timely, compliant disposition of products and records. Materials reviewed may include batch records, specifications, qualification and validation documents, stability protocols and reports, analytical and test reports, SOPs, certificates of analysis or testing, and periodic summary reports. The role reviews manufacturing and QC data for compliance with Good Documentation Practices and data verification requirements under 21 CFR 210/211. The position originates or reviews Quality Control exception documents and records, including OOS, OOT, deviation, CAPA, and change control records, to ensure regulatory and corporate compliance. It operates under established Quality Unit procedures and supervision. Final product disposition authority remains with designated, qualified, and authorized Quality Unit personnel.

Requirements

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 and the ability to promote intra- and interdepartmental cooperation.
High attention to detail.
Knowledge of GMP, ICH, and compendial requirements and their application.
Strong character, self-confidence, and integrity.

Responsibilities

Review executed manufacturing and filling batch records for completeness, contemporaneous documentation, adherence to approved instructions, critical process parameters, calculations, yields, material reconciliation, and traceability.
Ensure QC analytical data comply with GMP and GDP requirements.
Ensure QC documents and records comply with GMP, GDP, and corporate requirements.
Ensure exception documents and records comply with GMP, GDP, and corporate requirements and are closed before analytical testing disposition.
Review manufacturing and QCA/QCM records related to deviations, change controls, OOS investigations, and CAPAs.
Review in-process test results for executed batches and master filling records.
Review microbiology test data for release of raw materials, in-process materials, and final products.
Ensure QC documents are developed in accordance with domestic and international regulatory requirements and corporate standards.
Ensure analytical data are collected in compliance with 21 CFR Part 11; execute data analysis and verify data integrity.
Assist with client and regulatory audits and regulatory inspections.
Monitor manufacturing and laboratory notebooks to ensure timely issuance, review, and archival in accordance with established standards.
Review applicable environmental monitoring results, excursions, aseptic processing records, interventions, and contamination-related investigations for documented assessment of potential product impact.
Confirm that relevant equipment calibration, maintenance, qualification, and cleaning status, as well as applicable utilities or process monitoring records, have been addressed in batch review packages.
Work with manufacturing and quality control to resolve quality events in a compliant and timely manner.