This position plays a pivotal role in ensuring timely and compliant documentation within our regulated environment. You'll collaborate with document originators to guarantee accuracy, clarity, and adherence to GxP standards. Your expertise will extend to managing controlled documents within our Electronic Document Management System (eDMS), maintaining official copies, and overseeing document review and approval processes.
- Document Processing and Compliance: Oversee the processing of documents and associated historical data, ensuring strict adherence to GxP regulations and corporate policies.
- Document Control and Management: Finalize controlled documents in eDMS, maintain and distribute official copies, and facilitate the Document Periodic Review Program.
- Systems and Training: Contribute to departmental improvement projects, develop and deliver training on document systems, and manage data archival for off-site storage.
- Quality Assurance: Partner with the Quality Assurance Document Control (QADC) team to enhance document quality and execute updates through eDMS.
- Workflow and Database Maintenance: Update and maintain workflows and databases, ensuring efficient document management processes.
- Team Guidance and Support: Provide guidance to employees on document formatting requirements and departmental procedures.
- High School Diploma or equivalent with 5+ years of related experience, or Associates degree or equivalent with 3+ years of related experience.
- 2 years of experience in GMP document control.
- 1-2 years of experience with MS Office Suite, including proficiency in MS Word and MS Excel.
- Strong written and oral communication skills.
- Excellent time management skills and meticulous attention to detail.