Senior Specialist, Quality Systems

Essential Duties and Responsibilities

• Administer the electronic Quality Management System including document control, training records, and workflow management
• Manage the GxP training program including curriculum development, assigning, and tracking
• Collaborate with cross-functional stakeholders to ensure changes are documented, assessed and approved
• Support qualification and ongoing oversight of critical suppliers, maintain the GxP supplier list and coordinate supplier audits and questionnaires
• Prepare quality metrics for management review
• Aid in product complaint handling
• Generate and update product specifications, SOPs, templates, forms

Qualifications and Experience

• Minimum bachelors degree in relevant scientific discipline
• 5+ years experience in a clinical-phase biotech environment
• Hands-on experience with document control, training management, change/deviation management
• Strong written and verbal communication skills with the ability to author clear, concise quality documents
• Highly organized, detail-oriented, and able to manage multiple priorities simultaneously in a small-team environment