Reports To: Quality Assurance Manager
Purpose: Document Control Specialist is responsible for collecting, maintaining, archiving and retrieving all documents necessary to ensure compliance with Aurora Procedures and FDA regulations. The DC Specialist monitors production operations to ensure that all users have the latest accurate revision of appropriate documentation in a timely manner.
- Communicate cross functionally regarding current and emerging labeling timelines and issues*
- Review and coordinate approval process of artwork, packaging, graphics and text of existing product labels to ensure accuracy, consistency and regulation compliance*
- Effectively problem solve and leverage tools to minimize impact of sourcing, shipping and production of labels*
- Manages the life-cycle of the change process on approved labels*
- Store, manage and track company documents. Scan, image, organize and maintain documents, adhering to the company’s document lifecycle procedures, and archive records in accordance with the procedures*
- Coordinates storage, archiving, and retrieval of documents and quality system records with other departments*
- Ensure the proper documents are created and signed, that all data is accurate and that documents are stored and backed up and any retention procedures are followed*
- Ensures the timely and accurate processing of Change Orders (COs), master batch records and new documentation*
- Tracks training requirements for all departments*
- Confers with document originators to resolve discrepancies and compiles required changes to documents*
- Ensures documents meet approved format and template*
- Tracks and trends the effectiveness of document systems
- Maintains controlled documents register*
- Archives data*
- Supports the Quality Assurance Department by maintaining electronic files.
- Ensures orderly storage and expedient retrieval of all documentation according to Good Laboratory Practice (GLP) / Good Manufacturing Practice (GMP) regulations*
- Ensures the correct and timely input of database entries*
- Collaborates in cross-functional teams*
- Follows all Aurora Pharmaceutical policies, procedures, regulations and the employee handbook. *
- Follows designated work schedule. *
- Assumes additional responsibilities as requested. *
- Accepts and acts upon supervisory directions. *
- Demonstrates flexibility, i.e. willingly takes on new tasks. *
- Prioritizes projects and meets deadlines*
- (*Denotes essential job function)
Knowledge, Skills & Abilities:
- Superior attentiveness to detail.
- Extensive knowledge in MS Office, including MS Excel, MS Word, MS Access and MS Outlook.
- Excellent MS Word skills required: templates, styles, headers, working with cross referencing figures, tables and sections.
- Knowledge of Document Control fundamentals, Quality Systems and GMP requirements preferred.
- Bachelor degree preferred
- At least three years of experience working in a GMP environment required
This job description is subject to change at the sole discretion of Aurora Pharmaceutical.