QA Specialist, cGMP Compliance & Inspections

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, 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.