Shop Floor QA Lead: GMP & Quality Assurance

Mirus Consulting Group; Manatí (PR); Sur place; USD 90 000 - 120 000; Plein temps

Résumé du poste

mîrus Consulting Group seeks a Senior Quality Assurance Scientist - Shop Floor to oversee manufacturing QA and ensure GMP compliance. You will guide real-time decisions, review batch records and CAPAs, and work with Operations to uphold quality standards on the shop floor.

The role includes deviation investigations, procedures review, and support for site initiatives. Strong GMP knowledge and bilingual abilities are essential for success in this role in Puerto Rico.

Qualifications

• Bachelor’s degree in Science or Engineering with GMP responsibilities in pharma.
• 6 years of practical experience in Quality Systems or GMP environments.
• Fully bilingual (Spanish/English) with strong written and verbal skills.

Responsabilités

• Provide QA oversight of manufacturing to ensure compliance with GMP regulations and internal procedures.
• Support real-time decision-making on the shop floor with risk assessments and quality direction.
• Review and approve GMP documents, batch records and CAPA deliverables.
• Lead deviation investigations and assist with investigations and change control.
• Coach personnel on GMP principles during significant practice changes and site initiatives.
• Participate in inspections readiness and continuous improvement activities.

Connaissances

Problem solving

Critical thinking

Learning capability

Analytical thinking

Attention to detail

Formation

Bachelor’s degree in Science or Engineering

Outils

Microsoft Office

TrackWise

Infinity

SAP

Description du poste

mîrus Consulting Group seeks a Senior Quality Assurance Scientist - Shop Floor to oversee manufacturing QA and ensure GMP compliance. You will guide real-time decisions, review batch records and CAPAs, and work with Operations to uphold quality standards on the shop floor.

The role includes deviation investigations, procedures review, and support for site initiatives. Strong GMP knowledge and bilingual abilities are essential for success in this role in Puerto Rico.