Pharma QA Investigator & CAPA Specialist

Legal Project Management Partners; Barceloneta (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

Legal Project Management Partners in Puerto Rico seeks a QA Specialist to provide operational, scientific, and compliance expertise to support sterile and non-sterile manufacturing operations in a pharmaceutical environment. You will execute investigations, gather supporting information, and ensure timely closure of quality events.

You will collaborate with cross-functional teams to identify root causes, develop CAPAs, and maintain regulatory compliance while contributing to regulatory

Qualifications

• Bachelor's degree in Science, Pharmacy, or Engineering.
• Minimum 5 years in a parenteral manufacturing facility.
• At least 1 year of experience executing manufacturing or quality investigations.

Responsibilities

• Execute manufacturing investigations related to Quality Events (QEs), NTRs, and NOEs.
• Collect, coordinate, and assess information required to support investigations.
• Ensure QEs, NTRs, and NOEs are completed and closed within established timelines.
• Apply appropriate investigation and root cause analysis tools to identify causes and prevent recurrence.
• Prepare clear, accurate, and technically sound investigation reports and supporting documentation.
• Lead QE and CAPA trend evaluations to identify recurring issues and opportunities for improvement.
• Collaborate with Manufacturing, Quality, Engineering, and other relevant teams to develop effective corrective and preventive actions.
• Review and provide input to regulatory submissions within the assigned area of responsibility.
• Participate in regulatory inspections and support related activities as needed.
• Promote teamwork, accountability, and behaviors aligned with the organization's values.
• Support site initiatives and additional assignments based on business needs.

Skills

cGMPs knowledge

Root cause analysis

Technical writing

Statistical data interpretation

Microsoft Office

Bilingual English/Spanish

Education

Bachelor's degree in Science/Pharmacy/Engineering

Tools

Microsoft Office Suite

Job description

Legal Project Management Partners in Puerto Rico seeks a QA Specialist to provide operational, scientific, and compliance expertise to support sterile and non-sterile manufacturing operations in a pharmaceutical environment. You will execute investigations, gather supporting information, and ensure timely closure of quality events.

You will collaborate with cross-functional teams to identify root causes, develop CAPAs, and maintain regulatory compliance while contributing to regulatory