QA Investigation Writer - GMP, CAPA & Compliance

Kelly Science, Engineering, Technology & Telecom; Barceloneta (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

Kelly® Science, Engineering, Technology & Telecom (SETT) seeks an Investigation Writer to support quality investigations for a top global biopharmaceutical client in the Barceloneta, Puerto Rico area. The role involves QA investigation writing, CAPA coordination, and support across GMP-compliant processes.

The ideal candidate will be fully bilingual (English/Spanish) with a science or engineering background and at least four years in pharma quality or related fields.

Qualifications

• Bachelor’s degree in science or engineering; 4+ years in pharma quality or technical field.
• Knowledge of GMP and safety regulations.
• Excellent written and spoken English and Spanish.
• CAPA experience; authoring and approving investigations.
• Strong problem‑solving skills.
• Fully bilingual in English and Spanish.

Responsibilities

• Perform exception reports, complaints, PQRs, CP coordination and trend monitoring.
• Investigate activities when exceptions occur in manufacturing, labs, QC, validation, microbiology, or complaints.
• Lead and document CAPA investigations and ensure timely closure.
• Carry out complaint investigations in line with policies and regulatory requirements.
• Perform laboratory investigations when out-of-spec results arise; support IT systems for Expectation Events.
• Coordinate local change plans and assess strategies with end users.
• Generate periodic quality metrics on investigations, complaints, CP, PQRs, and KPIs.

Skills

English

Spanish

Communication

Education

Bachelor’s degree in science or engineering

Job description

Kelly® Science, Engineering, Technology & Telecom (SETT) seeks an Investigation Writer to support quality investigations for a top global biopharmaceutical client in the Barceloneta, Puerto Rico area. The role involves QA investigation writing, CAPA coordination, and support across GMP-compliant processes.

The ideal candidate will be fully bilingual (English/Spanish) with a science or engineering background and at least four years in pharma quality or related fields.