GMP QA Specialist - NPI & Continuous Improvement

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 80,000 - 110,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a focused Quality Assurance professional to join our team in Puerto Rico and the USA. You will review and approve cGMP manufacturing documents, batch records, and related quality systems across cross-functional teams.

The role involves supporting NPI, CAPA, change control, validation activities, and audits, with a focus on maintaining product quality and regulatory compliance in a fast-paced manufacturing environment.

Qualifications

• Bachelor's degree in Science or Engineering.
• Experience with New Product Introduction (NPI) processes.
• Knowledge of Change Control management and documentation.
• Experience with Factory Acceptance Tests (FATs).
• Knowledge of validation protocols and execution, including equipment and process validation.
• Experience supporting Process Performance Qualification (PPQ) activities.
• Knowledge of GMP and regulatory requirements.
• Ability to prepare, review, and maintain technical documentation.
• Experience in pharmaceutical, biotechnology, or medical device manufacturing environment preferred.

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.

Education

Bachelor's degree in Science or Engineering

Tools

SAP

TrackWise

EDMQ

DQMS

Job description

Quality Consulting Group, LLC is seeking a focused Quality Assurance professional to join our team in Puerto Rico and the USA. You will review and approve cGMP manufacturing documents, batch records, and related quality systems across cross-functional teams.

The role involves supporting NPI, CAPA, change control, validation activities, and audits, with a focus on maintaining product quality and regulatory compliance in a fast-paced manufacturing environment.