Senior QA Specialist - Pharma cGMP Compliance

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a talented QA professional to join our team in Puerto Rico and the US. You will perform on-the-floor QA reviews of cGMP manufacturing processes, batch records, and quality documentation.

The role requires strong analysis, problem-solving, and the ability to lead cross-functional teams, with English and Spanish communication skills and experience with audits and regulatory inspections. Bachelor’s degree in Science or Engineering is required.

Qualifications

• Bachelor's degree in Science or Engineering required.
• Experience in QA within pharmaceutical/biotech/medical device in regulated manufacturing.
• Strong knowledge of cGMP, quality systems, deviations, CAPA, change control, and validation.
• Experience with batch record review and manufacturing documentation.
• Experience supporting audits/inspections, commissioning, qualification, or GxP validation.
• Knowledge of computer systems validation/quality assurance desirable.
• Strong analytical and project management skills.
• Ability to lead cross-functional teams and influence stakeholders.
• Fluent in English and Spanish.

Responsibilities

• Perform on-the-floor QA 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 triaged, investigated, documented, and resolved per procedures and cGMP.
• Review and assess changes for potential impact to product quality and compliance.
• Support CAPA, change control, validation, and other Quality System activities.
• Coordinate with cross-functional teams to ensure compliance with procedures.

Skills

Quality Assurance

cGMP

Batch record review

Cross-functional collaboration

English/Spanish communication

Education

Bachelor's degree in Science or Engineering

Tools

SAP

TrackWise

EDMQ

MES/EBR

Job description

Quality Consulting Group, LLC is seeking a talented QA professional to join our team in Puerto Rico and the US. You will perform on-the-floor QA reviews of cGMP manufacturing processes, batch records, and quality documentation.

The role requires strong analysis, problem-solving, and the ability to lead cross-functional teams, with English and Spanish communication skills and experience with audits and regulatory inspections. Bachelor’s degree in Science or Engineering is required.