QA Investigator & CAPA Specialist

Johnson & Johnson Co.; Gurabo (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

Johnson & Johnson is seeking a QA Specialist - Investigation & CAPA in Gurabo, PR to ensure the Investigations and CAPA Quality System remains in compliance with GMP, company SOPs, and regulatory requirements.

You will evaluate records, collaborate cross-functionally, monitor performance metrics, and assist with inspections. English/Spanish communication skills are required, with a background in pharmaceutical QA.

Qualifications

• Bachelor’s degree in a science or engineering field is required.
• Minimum 2 years of experience in investigations and CAPA in the pharmaceutical industry.
• Experience in parenteral or biological manufacturing is preferred.
• Knowledge of cGMP and GMPs is required.
• Fluency in English and Spanish (oral and written) is required.

Responsibilities

• Evaluate and approve records for Quality Investigations and CAPA.
• Collaborate with J&J affiliates and JSC functions; handle complaints regarding products manufactured at the site; coordinate investigation strategies.
• Support QA oversight of the Investigations and CAPA system by monitoring performance and reporting metrics.
• Assist in regulatory inspections and ensure closure of GMP issues from audits.
• Provide feedback and review procedures, protocols, and other documents related to Investigations and CAPAs.
• Escalate compliance issues to the Quality Manager for Investigations and CAPAs.

Skills

Investigations

CAPA

cGMP

GMP

Quality Systems

Regulatory Knowledge

English & Spanish

Education

Bachelor’s degree in science or engineering

Tools

ASQ Certified Quality Auditor

Job description

Johnson & Johnson is seeking a QA Specialist - Investigation & CAPA in Gurabo, PR to ensure the Investigations and CAPA Quality System remains in compliance with GMP, company SOPs, and regulatory requirements.

You will evaluate records, collaborate cross-functionally, monitor performance metrics, and assist with inspections. English/Spanish communication skills are required, with a background in pharmaceutical QA.