QA Investigation Writer – Pharma & CAPA

Kelly Science, Engineering, Technology & Telecom; Barceloneta (PR); On-site; USD 60,000 - 90,000; Full time

Job summary

Kelly Science, Engineering, Technology & Telecom is seeking an Investigation Writer to support a global biopharmaceutical client in the Barceloneta, PR area. The role focuses on quality assurance investigations, CAPA coordination, and ensuring compliance with cGMP and Customer policies.

You will lead and participate in investigations across manufacturing, laboratories, and quality systems, document thoroughly, and drive timely corrective actions.

Qualifications

• Bachelor’s degree in science or engineering with 4+ years in quality/technical field in PHARMA/biotech.
• Advanced knowledge of GMP and safety regulations.
• Strong English and Spanish written/verbal communication.
• Experience in CAPA including authoring/approving investigations.
• Strong problem-solving skills.

Responsibilities

• Perform exception reports, complaints, PQRs, CP coordination and trend monitoring.
• Investigate events in manufacturing, labs, validation, or complaints areas.
• Ensure thorough investigation documentation and CAPA-based closure.
• Conduct complaint investigations ensuring policy/regulatory compliance.
• Lead or support laboratory investigations for out-of-spec results.
• Support plant users on Expectation Events IT Systems.
• Coordinate local change plans with end users and impacted areas.
• Produce periodic quality metrics on investigations and CPs.
• Provide New Product QA investigator writer support as needed.
• Assist during internal or external inspections.

Skills

Bilingual

QA Skills

Written English

Education

Bachelor’s degree

Biology/Chemistry

Job description

Kelly Science, Engineering, Technology & Telecom is seeking an Investigation Writer to support a global biopharmaceutical client in the Barceloneta, PR area. The role focuses on quality assurance investigations, CAPA coordination, and ensuring compliance with cGMP and Customer policies.

You will lead and participate in investigations across manufacturing, laboratories, and quality systems, document thoroughly, and drive timely corrective actions.