Senior QA Scientist – GMP/Parenteral Manufacturing

Legalpmpartners; Barceloneta (PR); On-site; USD 80,000 - 120,000; Full time

Job summary

Legal PM Partners is seeking an experienced Senior Quality Assurance Scientist to provide shop-floor QA oversight for pharmaceutical manufacturing and GMP operations. The role emphasizes risk-based decision making, review of batch records and GMP documentation, and support for investigations, CAPAs, and change controls.

Collaboration with Operations and cross-functional teams is essential to maintain product quality and inspection readiness. Bilingual in English and Spanish required.

Qualifications

• Bachelor’s degree in Science (Chemistry, Biology, Microbiology, Pharmacy, or Engineering).
• Six years of pharmaceutical-industry experience with GMP responsibilities.
• Three to five years of practical Quality Systems experience within a GMP manufacturing environment, including investigations, CAPA, and change control.
• Fully bilingual in English and Spanish; strong technical writing.

Responsibilities

• Conduct operational walkthroughs to assess manufacturing practices against GMP requirements.
• Review and approve manufacturing batch records, SOPs, specifications, technical reports, and other GMP documents within assigned authority.
• Coach deviation owners and review and approve investigation reports to support thorough, well-documented investigations.
• Lead or support Quality-owned investigations and impact assessments.
• Review corrective and preventive actions (CAPAs) to confirm alignment with identified root causes.
• Assess proposed process and procedural changes through the change control system.
• Manage audit observations, investigations, CAPAs, and change control records within the quality management system.
• Review and analyze supporting quality data to inform assessments and decisions.

Skills

Quality systems

GMP knowledge

Technical writing

Risk-based decision making

Cross-functional collaboration

Analytical thinking

Bilingual English/Spanish

Education

Bachelor’s degree in Science (Chemistry, Biology, Microbiology, Pharmacy, or Engineering)

Tools

TrackWise

Infinity

SAP

Job description

Legal PM Partners is seeking an experienced Senior Quality Assurance Scientist to provide shop-floor QA oversight for pharmaceutical manufacturing and GMP operations. The role emphasizes risk-based decision making, review of batch records and GMP documentation, and support for investigations, CAPAs, and change controls.

Collaboration with Operations and cross-functional teams is essential to maintain product quality and inspection readiness. Bilingual in English and Spanish required.