GxP Quality Document Control Specialist

Greenkey Resources LLC; Bedford (MA); On-site; USD 55,000 - 90,000; Full time

Job summary

Greenkey Resources LLC in the United States is seeking a Document Control Specialist, Quality to manage GxP documentation lifecycle, issue and reconcile documents, and ensure compliance with industry standards at the Gene Therapy Manufacturing Facility (GTMF).

You will collaborate with the Document Control team, organize electronic and paper records, and support audits to maintain GDP and cGMP compliance across operations.

Qualifications

• Bachelor’s Degree in a science, engineering, or related discipline is required.
• 1-4 years of experience in Quality within the pharmaceutical, biotech, or life-sciences industry preferred.
• Proficiency in document control systems and electronic document management tools.
• Strong organizational skills and attention to detail are essential for success.
• Knowledge of cGMP and GDP principles is highly desirable.
• Proficient in Microsoft Excel, Word, and PowerPoint for documentation tasks.
• Ability to work independently and manage multiple tasks effectively.

Responsibilities

• Adhere to SOPs and Work Instructions for document management.
• Manage storage at GTMF and GTQC facilities with proper archival.
• Organize and file documents for easy access and compliance.
• Support issuance, reconciliation, and retention of controlled documents.
• Assist audits by providing necessary documentation and support.
• Collaborate with internal and external subject matter experts.
• Maintain high ethical standards and professionalism in all activities.

Skills

Document control lifecycle

Regulatory compliance

Audit support

Cross-functional collaboration

Education

Bachelor's degree in science/engineering or related discipline

Tools

Electronic document management systems

Microsoft Excel

Microsoft Word

PowerPoint

Job description

Greenkey Resources LLC in the United States is seeking a Document Control Specialist, Quality to manage GxP documentation lifecycle, issue and reconcile documents, and ensure compliance with industry standards at the Gene Therapy Manufacturing Facility (GTMF).

You will collaborate with the Document Control team, organize electronic and paper records, and support audits to maintain GDP and cGMP compliance across operations.