Duties and Responsibilities

• Supports the implementation and continuous improvement of the company’s Quality systems
• Assists in monitoring of Serán quality systems through trending and metrics analysis
• Supports the management of Serán’s quality systems through program oversight and eQMS administrative functions.
• Document authorship, review, and approval of SOPs, reports, and quality records
• Oversight of investigation and CAPA program management
• Supports internal audits, client audits and regulatory inspections, as needed
• Other related duties as assigned

Required Skills and Abilities

• Knowledge of GMP and FDA regulations for clinical trial materials preferred
• 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
• Demonstrated experience in characterization and analytical techniques relevant to the pharmaceutical industry
• Demonstrated experience with advanced laboratory and data analysis skills preferred
• Strong analytical and problem-solving skills

Education and Experience

• Minimum of a Bachelor's Degree, preferably in a scientific discipline
• 3+ years previous manufacturing, quality control, or quality assurance experience
• Working knowledge of Veeva and/or SAP preferred

Physical Requirements

• Prolonged periods of sitting or standing at a desk and working on a computer
• Must be able to lift up to 15 pounds at times
• Ability to wear required personal protective equipment (PPE), including safety glasses, hearing protection, hard hat, and safety shoes
• Adheres to consistent and predictable in-person attendance