QA Specialist- Investigation and CAPA

Johnson & Johnson • Gurabo, PR

1d • Onsite

About The Position

The Quality Specialist (Investigations & CAPA) ensures that the Investigations and CAPA Quality System is maintained in compliance with established company and corporate standard operating procedures, policies, rules, regulations, and current GMP guidelines. The role is based in Gurabo, Puerto Rico, and supports Johnson & Johnson Innovative Medicine.

Requirements

• A minimum of two years of experience in related areas, such as management of investigations and CAPA processes, in the pharmaceutical industry.
• Expert understanding of cGMP, Good Documentation Practices, and regulations.
• Familiarity with US and international GMPs for pharmaceuticals.
• Good oral and written communication skills in both English and Spanish, including proficiency in technical writing.
• A minimum of a bachelor's degree is required.

Nice To Haves

• A bachelor's degree in Engineering, Chemistry, Biology, Biochemistry, Microbiology, Mathematics, or a related science is preferred.
• Experience related to parenteral manufacturing areas or biological manufacturing.
• ASQ Certified Quality Auditor.

Responsibilities

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level