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
Skills Required
- 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
- Strong knowledge of Good Documentation Practices and electronic quality systems
- Ability to collaborate effectively with Manufacturing, Engineering, and Process Development teams
- Bilingual English and Spanish communication skills
What We Do
The Quality Consulting Group is a pharmaceutical, biotechnology, food and medical device specialty consultant that supports the manufacturing industry; services are provided in multiple areas including: Regulatory Compliance, Quality Operations, Validation, Manufacturing, Training and Technical Support. Starting, as individual services provider since 2002, Quality Consulting Group has supported clients implementing the latest standards such as Validation Guidance, ICH Guidelines, and Process Excellence and Risk Management tools. Quality Consulting Group has provided expertise in such areas as: business, operational, quality, regulatory and manufacturing strategies; organizational structures; management controls; manufacturing and quality systems methodologies and practices; compliance programs; and accuracy reviews; FDA, EMEA and other regulatory matter
