Job Title: Document Control Technician

Job Description

As a Document Control Technician, you will guide documents through the creation and revision process, assisting authors, reviewers, and approvers with training. You will proofread, edit, format, route for review and approval, track document progress, copy, distribute, and file regulated documentation. Additionally, you will assign study numbers, document numbers for protocols and reports, and numbers for lab investigations and deviations. Your role includes implementing archive requirements, ensuring compliance with corporate policies for training, and maintaining employee qualification records.

Responsibilities

• Guide documents through the creation and revision process.
• Assist document authors, reviewers, and approvers through the document creation and revision process, including providing training.
• Proofread, edit, format, route for review and approval, track document progress, copy, distribute, and file regulated documentation.
• Assign study numbers, document numbers for protocols and reports, and numbers for lab investigations and deviations.
• Implement archive requirements including receiving, organizing, inventorying, tracking, and maintaining study and facility records.
• Assist in ensuring compliance with corporate policies and procedures for training requirements.
• Maintain evidence of training and employee qualification records, ensuring they are archived appropriately.
• Provide daily administration and technical support for the Document Management System to all local personnel.
• Assist with the maintenance of local document control and training SOPs.
• Provide assistance during local audits/regulatory inspections and assist with inspection preparation.
• Perform all activities in compliance with GLP (21 CFR Part 58).

Essential Skills

• Minimum of 5 years of experience in a quality role in a GLP or cGMP environment.
• Experience in document control.
• Strong writing skills and high proficiency in Microsoft Word.
• Excellent organizational and oral/written communication skills.
• Ability to multi-task and adapt quickly to a changing environment.

Additional Skills & Qualifications

• Degree in Biology, Chemistry, or related field is desired.
• Experience with R&D and GLP (21 CFR Part 58) training is preferred.
• Proficiency in Veeva Quality Vault and Training Vault is preferred.
• Strong team player with a demonstrated track record of success in a cross-functional team and fast-moving environment.

Work Environment

You will work with the R&D team in operations, spending some time at a desk. The role is based in a new state-of-the-art facility with a growing startup company in cell/gene therapy.