Data Entry, Quality Management System

Green Key Resources

New York City Metropolitan Area

Description

The client is seeking a highly accurate, detail-oriented Data Entry Support to join their team. In this contract, full-time role, you will be responsible for transferring, updating, and verifying large volumes of information across our internal systems. You will play a vital role in maintaining data integrity and supporting Quality Management System (QMS) activities within a GMP-regulated environment. This role will work closely with Quality consultants and requires experience with GMP quality processes including Deviations, CAPAs, Change Control, and Vendor Management.

Required experience working within a GMP Quality Management System (QMS), including hands-on experience with Deviations, CAPAs, Change Control, and Vendor Management processes.

Primary Responsibilities

Data Input

  • Efficiently transcribe information from emails and attachments to our ZenQMS system or a spreadsheet.

Quality Assurance

  • Verify data for accuracy, completeness, and consistency prior to entry. Identify and correct discrepancies or inconsistencies in existing records.

Quality Systems Support

  • Accurately enter, maintain, and update GMP quality records within ZenQMS.
  • Support the management and tracking of Deviations, CAPAs, Change Controls, and Vendor Management documentation.
  • Collaborate closely with Quality consultants to ensure quality records are complete, accurate, and compliant with internal procedures and regulatory requirements.

Compliance & Security

  • Handle confidential and sensitive company/customer information strictly in accordance with data protection protocols.

Required Skills and Qualifications

  • Strong GMP Quality Management System (QMS) experience is required.
  • 3 to 5 years of experience in data entry, quality systems administration, or document management within a GMP-regulated pharmaceutical, biotechnology, medical device, or life sciences environment.
  • Strong computer skills with a high level of proficiency using Microsoft 365 (especially Excel) and cloud-based systems
  • Typing speed of 85 to 100 wpm with 99% - 100% accuracy, a meticulous eye for detail to ensure data integrity and prevent costly errors
  • Excellent organizational skills with the ability to manage time efficiently in a deadline-driven environment
  • Strong analytical problem-solving skills, with the ability to escalate issues to the correct downstream collaborators
  • Clear verbal and written communication skills to liaise with team members and clarify data requirements