Quality Assurance Senior Specialist

Serán is seeking a Quality Assurance Senior Specialist who will be responsible for performing the day-to-day tasks of the QA Department supporting a GMP facility manufacturing, storing, and testing pharmaceutical products. Primary responsibilities include overseeing Supplier Quality, Auditing (supporting regulatory and client audits, conducting internal and vendor audits), and managing the Quality Risk Management program. Tasks include audit management, audit response, facilitating audit related continuous improvements, negotiating/processing Quality Agreements and continuous improvement. Additional responsibilities include Quality Management System, risk analyses, change management and investigations/CAPA.

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