Job description:

Job Title: Quality Assurance (QA) Specialist – QMS / Investigations (Injectables)

Location: Boca Raton

Salary: $70,000 – $80,000 per year

Experience Required: Minimum 10 years

Industry: Pharmaceutical / Biotech (Injectables)

Job Summary:

We are seeking an experienced Quality Assurance (QA) Specialist with strong expertise in Quality Management Systems (QMS) and pharmaceutical manufacturing, specifically within injectables. The ideal candidate will have extensive experience handling deviations, investigations, change control, and quality documentation while ensuring compliance with regulatory standards.

Key Responsibilities:

• Manage and oversee Change Control processes to ensure compliance with internal procedures and regulatory requirements.
• Conduct and review compliant investigations, including OOS (Out of Specification) and OOT (Out of Trend) events.
• Review and s...