Senior QA Investigator & CAPA Writer

Creative Solutions Services, LLC; Barceloneta (PR); On-site; USD 34,000 - 37,000; Full time

Benefits offered by this job

Root cause analysis cert

Job summary

Creative Solutions Services, LLC in Barceloneta, PR seeks a Senior Investigator Writer to provide QA support for the plant, lead investigations, coordinate local change plans, and ensure compliance with cGMP and client policies.

Requires a Bachelor's in science or engineering, strong English and Spanish, knowledge of CAPA and product quality investigations, and experience with complaints, PQRs, and lab investigations. This 6+ month contract pays $25–$27.48 per hour.

Qualifications

• Bachelor's degree in science or engineering with 4+ years in pharmaceutical/biotech quality or technical field.
• Proven knowledge of GMP and safety regulations.
• Fluent in English and Spanish (written and spoken).
• Experience authoring and approving CAPA investigations and other quality systems.

Responsibilities

• Perform exception reports, complaints, PQRs, CP coordination and trend monitoring per client policies and plant procedures.
• Investigate activities when an exception event occurs in manufacturing, labs, validation, microbiology, or complaints.
• Document and coordinate CAPAs and ensure timely closure and effectiveness.
• Support NPI and new product processes as QA liaison between clients and third parties.

Skills

Communication EN/ES

Bilingual

Problem solving

Quality systems familiarity

Education

Bachelor's in Science or Engineering

Master's in Science/Engineering (preferred)

Tools

CAPA system

PQR investigations

Job description

Creative Solutions Services, LLC in Barceloneta, PR seeks a Senior Investigator Writer to provide QA support for the plant, lead investigations, coordinate local change plans, and ensure compliance with cGMP and client policies.

Requires a Bachelor's in science or engineering, strong English and Spanish, knowledge of CAPA and product quality investigations, and experience with complaints, PQRs, and lab investigations. This 6+ month contract pays $25–$27.48 per hour.