Document Control Specialist II

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Job description

• Responsible for scanning records and verifying accuracy and completeness of scans.
• Issue QC data packets for test.
• Archives records and prepares records for offsite storage.
• Processes document workflows, reviewing documents for correct format and compliance with company templates.
• Scans records and verifies accuracy and completeness of scans.
• Prepares records for offsite storage, creating accurate document indexes and ensuring record integrity is maintained.
• Ensures the correct and timely implementation of document requests in editing of controlled documentation.
• Verifies own work.
• Performs general word processing support and assists Client personnel in resolving document format issues.
• Processes document workflows to ensure priority documents are promptly processed to meet timelines.
• Maintains, verifies, and ensures correct and complete database and logbook entries.
• Assists with maintaining systems to ensure integrity and security of all documents containing data relevant to product quality and/or quality systems processes.
• Maintains master documents and records (both hardcopy and electronic) as required by applicable regulations such that required documentation is retrievable and files are accurate, complete and well organized.
• Maintains and performs audit of control binders to ensure that adequate and accurate distribution has occurred.
• Implements corrective actions if discrepancies are found.
• Applies company policies and procedures to resolve a variety of routine issues.
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Keeps abreast of the basic requirements for compliance in own area of work.
• Participates as required in training on regulatory issues affecting own area of work.
• Notifies manager of regulatory compliance questions and issues.
• Follows Environmental, Health and Safety (EH&S) policies and procedures.
• Takes responsibility for safety in immediate work area.
• Notifies manager of all observed hazardous conditions or unsafe work practices.
• Performs other related duties and assignments as required and defined by management.
• Two years of document control experience in the pharmaceutical/biotech industry.
• Works under general supervision; showing a general level of independence.
• General knowledge of understanding of Document Control standards, practices, and principles.
• General knowledge of understanding of Quality Systems and applicable GMP regulations and standards.
• Demonstrates ability to perform detail-oriented work with a high degree of accuracy.

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