JT845 - SPECIALIST QA

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, a leader inthe 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
• 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 Good Manufacturing Practices (GMP) and regulatory requirements.
• Ability to prepare, review, and maintain technical documentation.
• Experience working in a pharmaceutical, biotechnology, or medical device manufacturing environment preferred.
• Administrative Shift

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.