Pharma QA Specialist: cGMP & Continuous Improvement

Mirus Consulting Group; Juncos (PR); On-site; USD 75,000 - 110,000; Full time

Job summary

mîrus Consulting Group is seeking a Specialist QA to provide on-the-floor quality assurance oversight ensuring cGMP compliance and adherence to internal procedures and regulatory requirements. The role supports manufacturing operations through QA review of records, investigations, validations, quality systems, and continuous improvement initiatives while partnering across functions.

The candidate will enforce deviations, CAPAs, and validation activities, collaborate with multiple departments,

Qualifications

• Bachelor's degree in a related technical field.
• Minimum of 4 years of QA experience in regulated environments.
• Strong knowledge of Quality Systems: Deviations, CAPA, Change Control.
• Experience with electronic quality and manufacturing systems (MES, EBR, SAP, TrackWise).
• Bilingual in English and Spanish (written and verbal).

Responsibilities

• Perform on-the-floor QA review, approval, and tracking of cGMP processes, procedures, testing methods, and records.
• Lead and participate in continuous improvement initiatives and projects.
• Assess changes potentially impacting product quality according to procedures.
• Investigate and document deviations; ensure deviation records are initiated.
• Ensure production records and testing results are complete and compliant with procedures.

Skills

Quality Assurance

GxP Knowledge

Bilingual English/Spanish

CAPA Management

Change Control

Education

Bachelor's Degree in Science/Engineering

Tools

MES

TrackWise

SAP

Job description

mîrus Consulting Group is seeking a Specialist QA to provide on-the-floor quality assurance oversight ensuring cGMP compliance and adherence to internal procedures and regulatory requirements. The role supports manufacturing operations through QA review of records, investigations, validations, quality systems, and continuous improvement initiatives while partnering across functions.

The candidate will enforce deviations, CAPAs, and validation activities, collaborate with multiple departments,