Overview: We are seeking a detail-oriented Document Specialist to join our team. The ideal candidate will have expertise in document management systems, proofreading, and data entry. As a Document Specialist, you will play a crucial role in maintaining accurate and organized documentation for the department.
Specialist will aid the Document Control program in the Quality Control Department, including day to day document processing, document archiving, and supporting continuous improvement of documents. In addition, works with Document Control Manager and other managers and supervisors to assist and coordinate QC activities.
Duties:
-Review GMP documents for completeness, consistency, formatting, and adherence to company guidelines.
-Conduct thorough reviews of QC documents, including standard operating procedures, work instructions, protocols, batch records, and reports, to ensure accuracy and compliance with regulatory requirements.
-Maintain and update document control systems, including document tracking, version control, and archival processes, to ensure efficient retrieval access.
-Ensure proper document formatting, numbering, and filing conventions are followed consistently.
-Support internal and external audits, by providing accurate and timely documentation as requested.
-Identify and escalate document-related issues or discrepancies to appropriate personnel for resolution.
-Assist in the development and implementation of document control procedures and best practices to enhance efficiency, accuracy, and compliance.
-Manage periodic reviews and/or internal audits of controlled documents, as well as Department quality records, including training documentatio, audit documentation, amongst others.
- Provide backup support for GLP, GMP training program.
-Assists Quality Control team with writing of laboratory documentation, including Batch Records, Change Controls, Investigations, and more.
-Educate new and existing employees about document control and Good Documentation Practice requirements.
-Assist with archiving paper documentation.
-Perform other duties as need/requested.
Qualifications:
- Bachelor's degree in a relevant field (e.g. life sciences, engineering, quality assurance) or equivalent experience.
Experience:
- Proven experience as a document specialist or in a quality control role within a regulated industry (e.g., pharmaceuticals, medical devices, manufacturing).
Knowledge, Skills, and Abilities
- Strong understanding of quality control principles and regulatory guidelines (e.g. FDA, ISO). Excellent attention to detail and exceptional organizational skills to handle multiple documents and tasks simultaneously. Excellent written skills and the ability to write cohesive documentation. Proficient in using document control systems and software. Knowledge of Microsoft Office. Strong interpersonal and communication skills to collaborate effectively with cross-functional teams.Ability to work independently with minimal supervision while maintaining a high level of accuracy and quality. Bilingual preferred.
Job Type: Full-time
Benefits:
Schedule:
- 10 hour shift
- 8 hour shift
- Day shift
- Monday to Friday
- Overtime
Experience:
- Document management systems: 2 years (Required)
Ability to Commute:
- Miami, FL 33147 (Required)
Work Location: In person