Quality Assurance Specialist

Onsite role-St. Louis, MO

ONLY W2 Candidates can apply....

Key Responsibilities

• Lead and maintain the Quality Management System (QMS) in accordance with ISO 17025 standards.
• Support and manage quality documentation using MasterControl (QMIS).
• Conduct software validation and documentation review.
• Perform root cause investigations and implement CAPAs (Corrective and Preventive Actions).
• Develop and maintain internal quality procedures (IQPs) and Quality Implementation Plans (QIPs).
• Work with FDA staff and stakeholders to improve systems and ensure compliance.
• Support audit readiness, reporting, and process improvements.
• Produce monthly progress reports and maintain FDA-required records.

Required:

• Bachelor’s degree in a scientific, technical, or engineering field.
• 5+ years of experience in Quality Assurance, ideally in a regulated lab or pharmaceutical setting.
• Familiarity with ISO 17025, QMS operations, and document control systems.
• Experience using MasterControl or other electronic QMS platforms.
• Strong analytical, communication, and technical writing skills.

Preferred:

• Experience working with or for a government health agency (e.g., FDA, NIH).
• Knowledge of GMP, GLP, and related quality standards.

Job Types: Full-time, Contract

Pay: $90,000.00 - $100,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Work Location: In person