Job Title: Quality Management Documentation Senior Specialist
Location: Remote
Contract Type: Contract
About the Role
We are seeking a Quality Management Documentation Senior Specialist to support the development and maintenance of GxP Quality Management Documents (QMDs) in compliance with a global Quality Management System (QMS). This role requires exceptional attention to detail, strong communication skills, and the ability to work to tight timelines while ensuring accuracy and compliance.
Key Responsibilities
* Perform document control activities, ensuring consistency and compliance with applicable standards and procedures for QMD lifecycle management.
* Manage external distribution of QMDs to support project teams, audits, and inspections.
* Collaborate with internal stakeholders to ensure compliance with QMS and QMD lifecycle requirements.
* Format, QC, and publish QMDs and related deliverables with exceptional accuracy.
* Proofread and edit QMDs to ensure clarity, accuracy, and adherence to internal standards.
* Identify and correct errors and formatting issues.
Skills and Experience
* Bachelor’s degree in life sciences or a related discipline.
* Minimum of 3 years of experience with document management systems.
* Experience managing GxP procedural documents.
* Strong proficiency with Microsoft Word, Excel, SharePoint, PowerPoint, and Visio.
* Excellent written and verbal communication skills.
* Strong critical thinking, teamwork, and interpersonal skills.
* Experience in technical writing or editing is preferred.
* Familiarity with Visio or similar diagramming tools is a plus.
* Understanding of the drug development process is desirable.