Document Control Specialist
Document Control Specialist
Purpose: Document Control Specialist is responsible for collecting, maintaining, archiving and retrieving all documents necessary to ensure compliance with GMP and FDA regulations. DC Specialist develops and maintains a comprehensive filing system and computer database for all documents to be retained in the document control center. Manages the operation of the document control center to ensure that all users have the latest accurate revision of appropriate documentation in a timely manner.
- Updates, reviews and releases Standard Operating Procedures, Departmental Procedures and forms*
- Coordinates storage, archiving, and retrieval of documents and quality system records*
- Maintains Master Batch Records and other production documents*
- Processes and monitors Change Order and Deviation reports for approval, completeness and implementation*
- Ensures the timely and accurate processing of Change Orders (COs), master batch records and new documentation*
- Qualifies vendors*
- 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 to support their quality documentation
- Ensures orderly storage and expedient retrieval of all documentation according to Good Laboratory Practice (GLP) / Good Manufacturing Practice (GMP) regulations*
- Maintains testing standards and other QC documents
- Issues master documents to support QC and Production*
- 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.
- HS Diploma
- At least three years of experience working in GMP environment
This job description is subject to change at the sole discretion of Aurora Pharmaceutical.