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Quality Assurance Associate, Document Management Specialist

1 month ago


Summit, New Jersey, United States Omni Inclusive Full time

Omni Inclusive is committed to offering a competitive salary for this role, estimated at $65,000 - $75,000 per year, based on the location and industry standards.

About the Job

The Quality Assurance Associate will be responsible for ensuring accurate and timely maintenance and review of quality records and manufacturing documentation. This role requires strong organizational skills, attention to detail, and the ability to work independently with minimal supervision.

Key Responsibilities

  • Supports the receiving of executed batch records and ensures their accuracy and completeness.
  • Assists in scanning and uploading quality records, maintaining inventory, and adhering to cGMP regulations.
  • Collaborates with cross-functional teams to ensure requirements are met and contributes to the goals within the work group.
  • Demonstrates excellent verbal and written communication skills, preparing clear and concise reports and presenting information effectively.
  • Maintains a positive working relationship with colleagues, supervisors, and external partners.

Requirements

  • Bachelor's degree with 1-3 years of experience in GMP manufacturing or a related field.
  • Equivalent combination of education and experience acceptable.
  • Knowledge of US and global cGMP requirements.
  • Ability to effectively multi-task, prioritize tasks, and manage time efficiently.

Working Conditions

This role is performed in a typical office environment with standard equipment and lighting conditions. Work involves sitting for extended periods, with occasional standing and walking required.