QA Specialist - Pharma Investigations & CAPA Lead

Legalpmpartners; Barceloneta (PR); On-site; USD 62,000 - 83,000; Part time

Job summary

Legalpmpartners in Puerto Rico is seeking a QA Specialist to provide operational, scientific, and regulatory compliance support for sterile and non-sterile pharmaceutical manufacturing. The role focuses on investigations, CAPAs, and timely closure of quality events.

You will lead root-cause analyses, collaborate with Manufacturing, Quality, Engineering, and other teams, and contribute to regulatory submissions and inspections.

Qualifications

• Bachelor’s degree in Science, Pharmacy, or Engineering.
• Minimum of five years in a parenteral manufacturing facility.
• At least one year executing manufacturing or quality investigations.
• Experience with cGMPs and regulatory standards.

Responsibilities

• Execute manufacturing investigations related to Quality Events (QEs), NTRs, and NOEs.
• Collect, coordinate, and assess information required to support investigations.
• Ensure QEs, NTRs, NOEs are completed and closed within established timelines.
• Apply investigation and root cause analysis tools to identify causes and prevent recurrence.
• Prepare clear, accurate investigation reports and supporting documentation.
• Lead QE and CAPA trend evaluations to identify recurring issues.
• 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

cGMP knowledge

Regulatory understanding

Technical writing

Presentation skills

Bilingual English/Spanish

Education

Bachelor’s degree (Science/Pharmacy/Engineering)

Tools

Microsoft Word

Excel

PowerPoint

Job description

Legalpmpartners in Puerto Rico is seeking a QA Specialist to provide operational, scientific, and regulatory compliance support for sterile and non-sterile pharmaceutical manufacturing. The role focuses on investigations, CAPAs, and timely closure of quality events.

You will lead root-cause analyses, collaborate with Manufacturing, Quality, Engineering, and other teams, and contribute to regulatory submissions and inspections.