JT807 - SPECIALIST QA

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:
• Perform on-the-floor Plant Quality Assurance (PQA) review and approval of cGMP manufacturing processes, procedures, testing methods, documents, and production records
• Review and approve batch records, MES/EBR, SAP, EDMQ, DQMS, and TrackWise documentation, including deviations, CAPAs, and validations
• Ensure deviations and quality events are properly triaged, investigated, documented, and resolved in accordance with procedures and cGMP requirements
• Review and assess changes for potential impact to product quality and compliance
• Support and oversee CAPA, change control, validation, and other Quality System activities
• Partner cross-functionally with Manufacturing, Process Development, Validation, Quality Control, Warehouse, Engineering, Facilities, Environmental, and Contractors to ensure compliance with established procedures
• Provide Quality support for New Product Introduction (NPI) and complex projects
• Support internal and external audits and regulatory inspections, serving as a Quality representative when required
• Support commissioning and qualification activities and GxP application validation, including risk assessments and IQ/OQ/PQ documentation
• Analyze quality data and trends, evaluate compliance issues, and provide recommendations to address quality and operational risks
• Participate in and lead continuous improvement initiatives and quality projects
• Communicate quality, compliance, supply, and safety risks to appropriate levels of management
• Work independently while effectively leading, influencing, and collaborating with cross-functional teams

Qualifications:
• Bachelor's degree in Science or Engineering
• GMP manufacturing experience in Quality Assurance
• Experience reviewing and approving Change Controls, Deviations, CAPAs, protocols, reports, and procedures.
• Experience supporting packaging and inspection operations preferred.
• Strong knowledge of Good Documentation Practices (GDP) and electronic quality systems
• Ability to collaborate effectively with Manufacturing, Engineering, and Process Development teams
• Bilingual English/Spanish communication skills preferred
• Administrative Shift