Document Control Specialist, Quality

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

Document Control Specialist, Quality Overview

• The Document Control Specialist, Quality will manage GxP documentation lifecycle processes, focusing on issuance and reconciliation, ensuring compliance with industry standards.
• Collaborate with the Document Control team to support daily operations and process improvements for document management systems.
• Maintain and organize high volumes of documentation in both electronic and paper-based formats, ensuring accessibility and accuracy.
• Provide support during internal and external audits, ensuring all documentation meets regulatory standards and guidelines.
• Act as a key resource for document control activities at the Gene Therapy Manufacturing Facility (GTMF).
• Ensure compliance with GDP and cGMP principles in all document management activities.
• Communicate effectively with internal departments to prioritize and address documentation needs.

Document Control Specialist, Quality Key Responsibilities & Duties

• Adhere to Standard Operating Procedures and Work Instructions for document management processes.
• Manage document storage activities at the GTMF and GTQC facilities, ensuring proper archival and retrieval.
• Organize and file documents systematically for easy access and compliance with regulatory requirements.
• Support the issuance, reconciliation, and retention of controlled documents and records.
• Assist in preparing for audits and inspections by providing necessary documentation and support.
• Collaborate with internal and external subject matter experts to ensure documentation accuracy and compliance.
• Maintain high ethical standards and professionalism in all document control activities.

Document Control Specialist, Quality Job Requirements

• 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.