Quality Assurance Scientist

Location: North Area, Puerto Rico
Industry: Pharmaceutical Manufacturing
Schedule: Availability for rotating 8- or 12-hour shifts, irregular hours, weekends, and holidays as needed.

POSITION SUMMARY

Legal PM Partners is seeking an experienced Senior Quality Assurance Scientist to provide shop-floor Quality Assurance oversight for pharmaceutical manufacturing and related GMP operations.

This professional will apply risk-based judgment to support quality decisions, assess operational practices, review manufacturing batch records and GMP documentation, and support investigations, corrective and preventive actions, and change controls.

The selected candidate will work closely with Operations and cross-functional teams to maintain product quality, regulatory compliance, and inspection readiness. The ideal candidate will bring practical Quality Systems experience, knowledge of parenteral manufacturing, and strong technical writing and problem-solving skills.

MAIN RESPONSIBILITIES

• Conduct operational walkthroughs to assess manufacturing practices against approved procedures and applicable GMP requirements.

• Partner with Operations to address quality concerns, reinforce compliant practices, and maintain inspection readiness.

• Make risk-based QA decisions regarding planned and unplanned events, assess potential impact on validated processes, and escalate significant quality issues.

• Review and approve manufacturing batch records, standard operating procedures (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.

• Support qualification and validation documentation, media fills, equipment maintenance and calibration activities, and monitoring of quarantine storage conditions.

• Perform sampling and finished-product evaluations when assigned to inspection or packaging activities, including applicable acceptance quality checks.

• Support annual product quality reviews, product transfers, site projects, continuous improvement initiatives, and departmental budget activities.

• Prepare and deliver GMP training and quality communications.

• Assist during internal audits and regulatory inspections.

GENERAL REQUIREMENTS

• Knowledge of parenteral manufacturing operations.

• In-depth understanding of current Good Manufacturing Practices (cGMP), FDA requirements, and European Union regulations applicable to pharmaceutical operations.

• Strong technical writing and document review skills, with attention to accuracy, clarity, and completeness.

• Strong analytical thinking, problem-solving, and risk-based decision-making skills.

• Ability to collaborate with Operations and cross-functional teams while providing sound quality guidance.

• Strong organizational skills and the ability to manage multiple quality activities and priorities.

• Fully bilingual in English and Spanish, with excellent written and verbal communication skills.

• Proficiency with Microsoft Office and quality/business applications such as TrackWise/Infinity and SAP.

• Lean/Six Sigma training or certifications preferred.

EDUCATION & EXPERIENCE

• Bachelor’s degree in Science, such as Chemistry, Biology, Microbiology, or Pharmacy, or a degree in Engineering.

• Six (6) years of pharmaceutical-industry experience in roles involving GMP responsibilities.

• Three to five (3–5) years of practical Quality Systems experience within a GMP manufacturing environment, including investigations, CAPA, and change control.

WORK SCHEDULE & CONDITIONS

• The position supports manufacturing and GMP operational areas in the North Area of Puerto Rico.

• Candidates must be available for rotating 8- or 12-hour shifts, irregular hours, weekends, and holidays, as operational needs require.

• Compliance with gowning procedures and use of area-specific personal protective equipment (PPE) are required.

• Operational visits may involve limited exposure to hazardous areas.

• Assignments involving inspection and packaging require successful completion of applicable sight-screening requirements and the ability to maintain sustained visual concentration.