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