Quality Assurance Senior Specialist

Duties & Responsibilities

• Performs internal and third-party audits.
• Supports regulatory inspections and client audits. Manages and improves audit program.
• Provides direction on audit operational activities and the development of audit responses, CAPA plans, and Effectiveness Checks.
• Oversees company’s supplier quality program including supplier qualification and audit (some travel required)
• Assists in the oversight, facilitation, and implementation of continuous improvement of the company’s quality systems
• Administers the quality risk management program and conducts risk assessments
• Document authorship, review, and approval of SOPs, reports, and quality records.

Required Skills & Abilities

• Knowledge of GMP and FDA regulations for drug manufacturing (21CFR 210-211).
• Knowledge of GMP, FDA, and EMA expectations for clinical trial and commercial materials, manufacturing, and testing
• Excellent verbal and written communication skills
• Excellent time management skills with a proven ability to meet deadlines
• Excellent organizational skills and attention to detail
• Demonstrated ability to collaborate and work in cross-functional teams
• Scientific curiosity and willingness to learn
• Strong analytical and problem-solving skills
• Ability to prioritize tasks and to delegate them when appropriate

Education & Experience

• Minimum of a Bachelor's Degree, preferably in a scientific discipline
• 8+ years previous quality assurance experience including Auditing and Supplier Quality experience
• Working knowledge of Veeva preferred

Physical Requirements

• Prolonged periods of sitting at a desk and working on a computer
• Must be able to lift up to 15 pounds