Senior QA Analyst — GMP Quality & Compliance

Creative Solutions Services, LLC; Barceloneta (PR); On-site; USD 41,000 - 45,000; Full time

Job summary

Creative Solutions Services, LLC seeks a Senior Quality Analyst/QA Specialist II in Barceloneta, PR for a 12-month onsite assignment. The role focuses on implementing and maintaining the Quality System and supporting manufacturing operations in investigations, risk assessment, and product disposition.

Responsibilities include ensuring GMP compliance, leading investigations, and collaborating with QA and Plant departments.

Qualifications

• Bachelor's degree in a scientific/engineering discipline and 4+ years in pharma/biotech quality/compliance.
• Experience with GMP, investigations, risk management, and regulatory standards for biological products.
• Strong written and spoken communication in English and Spanish.

Responsibilities

• Support quality goals and ensure compliance with policies and regulations for Quality areas.
• Lead and back up QA Manager, supporting quality initiatives across the plant.
• Conduct product impact analyses and approve investigations and risk-based evaluations.

Skills

Quality management

GMP knowledge

Regulatory compliance

Investigations

English/Spanish bilingual

Education

Bachelor's degree in Biotechnology/Biology/Chemistry/Engineering

Master's degree in Science preferred

Job description

Creative Solutions Services, LLC seeks a Senior Quality Analyst/QA Specialist II in Barceloneta, PR for a 12-month onsite assignment. The role focuses on implementing and maintaining the Quality System and supporting manufacturing operations in investigations, risk assessment, and product disposition.

Responsibilities include ensuring GMP compliance, leading investigations, and collaborating with QA and Plant departments.