JT768 - 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 quality-focused professional to join our team in Puerto Rico & USA. You will perform on-the-floor QA reviews of cGMP processes and documentation, ensuring deviations, CAPA, and validations meet regulatory standards.

Responsibilities include batch record review, cross-functional collaboration, and support for audits, NPI, and quality improvements. Strong English/Spanish communication and a science/engineering degree are required.

Qualifications

• Bachelor's degree in Science or Engineering required.
• Experience in Quality Assurance within a pharmaceutical, biotechnology, medical device, or other highly regulated manufacturing environment.
• Strong knowledge of cGMP, Quality Systems, deviations, CAPA, change control, and validation.
• Experience with batch record review and manufacturing documentation.
• Experience supporting NPI, audits/inspections, commissioning, qualification, or GxP validation.
• Knowledge of computer systems validation / computer systems quality assurance is highly desirable.

Responsibilities

• Perform on-the-floor QA reviews 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 triaged, investigated, documented, and resolved per 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.
• 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 management.

Skills

Quality Assurance

cGMP compliance

Documentation review

Cross-functional collaboration

Audit support

English & Spanish communication

CAPA / change control

Education

Bachelor's degree in Science or Engineering

Tools

SAP

TrackWise

EDMQ

DQMS

MES/EBR

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 in Quality Assurance within a pharmaceutical, biotechnology, medical device, or other highly regulated manufacturing environment.
• Strong working knowledge of cGMP, Quality Systems, deviations, CAPA, change control, and validation.
• Experience with batch record review and manufacturing documentation.
• Experience supporting NPI, audits/inspections, commissioning, qualification, or GxP validation.
• Knowledge of computer systems validation / computer systems quality assurance is highly desirable.
• Strong analytical, problem-solving, organizational, and project management skills.
• Ability to lead cross-functional teams and effectively influence and negotiate with stakeholders.
• Strong English and Spanish written and verbal communication skills.
• Proficiency with word processing, presentation, database, and spreadsheet applications.
• Ability to evaluate compliance issues and interpret quality data/trends.
• Ability to work independently and interact effectively with employees and leadership at all organizational levels.
• Non-Standard 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.