Job Title: Quality Associate

Job Description

The Quality Associate will work closely with the QA team and is responsible for maintaining all labeling files in accordance with internal procedures. The role involves coordinating labeling projects to ensure regulatory compliance and providing guidance to team members on labeling regulations and process requirements. The Quality Associate must understand GMP and come from generic pharmaceutical, following SOPs diligently.

Responsibilities

• Maintain all labeling files according to internal procedures.
• Coordinate labeling projects to ensure regulatory compliance.
• Provide guidance on labeling regulations and process requirements.
• Initiate, review, and implement label creation and updates with meticulous attention to detail.
• Provide regular updates on labeling projects to cross-functional departments to facilitate coordination for project completion timelines.

Essential Skills

• Ability to function well under pressure and balance multiple projects.
• Dedicated, detail-oriented focus in project initiation and management.
• Ability to take and follow directions.
• Familiarity with FDA Labeling guidelines (21 CFR).
• Excellent communication and organizational skills.
• Proficiency with Microsoft Office programs (Word, Excel, PowerPoint, Outlook).
• Knowledge of global medical device labeling requirements.

Additional Skills & Qualifications

• Bachelor's degree or equivalent experience.
• Experience with translation activities.
• Team player and flexible to work as per priority.

Work Environment

The role is situated within the generic pharmaceutical industry, providing a dynamic environment where teamwork and regulatory compliance are paramount. The work involves collaboration with various departments and requires adaptability to changing priorities.