Essential Functions/Responsibilities
- Develop and maintain a robust document control system for quality-related documents. - Ensure proper creation, review, approval, distribution, and archiving of all quality documents.- Establish and enforce documentation standards, including formatting, version control, and change management procedures. - Facilitate the archiving and disposal of documents in accordance with retentionpolicies. - Ensure compliance with regulatory and industry standards (e.g., ISO, CAP, CLIA, GLP, GCP, FDA). - Train staff on document control processes and procedures. - Serve as a point of contact for document-related inquiries and support - Conduct internal audits and support regulatory inspection. - Monitor site key performance indicator (KPI) and provide reports for management review.
Minimum Requirements
- High school diploma or equivalent - Requires 2 years of Document Control experience - Requires 1-3 years of related laboratory experience - Previous experience in document control or quality management (Veeva Vault), preferably in a regulated environment. - Willing and able to work under the pressure of deadlines and find solutions to meet timelines - Ability to work across teams by being a flexible team player with strong communication and interpersonal skills - Comfortable using computers, including a working knowledge of Microsoft Office programs, e-mail, and Internet. - Exceptional organizational and time-management skills. - Ability to multi-task with a high degree of professionalism and diplomacy.
Preferred Requirements
- Laboratory working experience in CLIA, GxP, and ISO 9001 environment is preferred - Experience with Veeva Vault e-QMS is preferred.
