Quality Systems Specialist

Job Description

Job Description

Our client, a global leader in Assisted Reproductive Technology (ART) is seeking a Quality Systems Specialist on a consulting basis to support the implementation of a new eQMS platform. This long-term contract offers the opportunity to contribute to the advancement of quality operations in a highly regulated and innovative environment.

Responsibilities:

• Process new and revised controlled documents through the electronic Quality Management System (eQMS).
• Perform document formatting, editing, and quality checks for accuracy and consistency.
• Maintain document revision histories and approval workflows.
• Ensure approved documents are distributed and available at points of use.
• Archive obsolete documents in accordance with document retention requirements.
• Maintain records in compliance with internal procedures and regulatory requirements.
• Assist with training record administration and tracking.
• Support preparation for internal and external audits.
• Monitor document control metrics and report status as required.
• Assist departments with document-related inquiries and process guidance.
• Perform periodic reviews of controlled documentation to ensure current status.
• Support GMP documentation and records management activities.
• Maintain confidentiality of company records and proprietary information.
• Participate in quality improvement initiatives related to document management processes.

Education:

• High School Diploma or equivalent required.
• Associate degree or coursework in Quality, Life Sciences, Business Administration, or a related discipline preferred.

Experience:

• 0 to 2 years of experience in document control, quality assurance, records management, or administrative support.
• Experience in a regulated industry (Medical Device, Pharmaceutical, Biotechnology, IVD, or similar FDA-regulated environment).