QARA Associate

QARA Associate - Permanent - Onsite

Proclinical Staffing is seeking a QARA Associate to join a cutting-edge pharmaceutical company. This is a permanent role located in New Jersey.

Primary Responsibilities

In this role, you will support various quality assurance and regulatory affairs activities to ensure compliance with industry standards and regulations.

Skills & Requirements:

• 1+ years of relevant work experience, preferably in a pharmaceutical manufacturing setting
• Exposure to regulatory submissions is advantageous
• Bachelor's degree in a relevant subject area
• Familiarity with FDA labeling guidelines is a plus
• Knowledge of GMP (Good Manufacturing Practices) and Quality Management Systems
• Must be currently a US citizen or Green Card holder

The QARA Associate will:

• Submission of recalls and support in managing recall processes
• Participate in GMP audits ensuring adherence to regulatory requirements
• Post-market surveillance activities by gathering and organizing data
• Review documents for accuracy and compliance
• Managing complaints and participate in coordinating complaint resolution processes
• Coordinating labeling projects to ensure regulatory compliance.

Compensation:

$50,000 - $60,000 annually

If you are having difficulty in applying or if you have any questions, please contact Ollie Archer at (+1) 347-410-8645 or o.archer@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.