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