Archival Specialist

About the role

This position is responsible for receiving, reconciling, scanning, uploading, reviewing, and approving all paper batch records, charts, and other manufacturing data. The Archival Specialist archives all paper-based documentation in physical locations, tracks records, and prepares them for transfer to offsite storage.

Responsibilities

• Receives all paper batch record documentation into the Scanning Center.
• Reconciles all control printed procedures not related to process orders within the document management system and physically archives them in the Product Release records room.
• Prepares paper documents for scanning by removing staples and paperclips.
• Ensures all attachment pages are copied, approved, and included within the document to be scanned.
• Ensures all documents to be scanned have process orders preceding the batch record.
• Utilizes document scanners and Kofax scan solution software to scan process order-related paper batch records into SAP DMS.
• Reviews each page of the scanned batch record for readability, completeness, and conformity with the original paper document.
• Checks batch, material, and order numbers against the scanned document and index fields on screen.
• Verifies scan completeness by comparing the number of pages of the paper document with the electronic document, approving via e-signature in the Kofax workflow.
• Ensures image quality, legibility, and proper alignment of pages; rescans documents if issues are noted.
• Ensures readability of embedded drawings, images, diagrams, labels, and charts.
• Troubleshoots scanners and software, entering ITSMs if issues cannot be resolved within the Scan Center.
• Performs routine cleaning of scanners to maintain high-quality scanning operations.
• Prepares batch records and other archived documentation for off-site storage by tracking record locations on the SharePoint records management site.
• Generates and sends monthly document reconciliation reports.
• Performs routine tasks within the QA Release Dept., including administrative duties and ordering supplies.
• Fosters a culture of continuous improvement through employee selection, training, and mentoring, focusing on operational efficiency and eliminating non-value-added activities.
• Provides a positive and equitable working environment emphasizing CSL Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance.
• Complies with CSL Behring’s Safety Program, including Health and Safety mandates and OSHA requirements.
• Completes any other duties or responsibilities assigned by Senior Management.

Requirements

• Associate’s degree, preferably in Library Sciences, or a High School Diploma with at least 2 years of experience in a regulated industry or in data/records archival management.
• Preferred experience in data records management, scanning, and electronic archival.
• Experience in a GMP or regulated environment is preferred.
• Excellent computer and organizational skills.
• Ability to work independently with little or no direction.
• Strong attention to detail and ability to meet deadlines.
• Ability to interact well with peers and customers.
• Ability to handle changing priorities with a positive attitude.

Skills

• Communicates effectively
• Customer focus
• Resourcefulness
• Situational adaptability
• Tech-savvy
• Optimizes work processes

Working Conditions

• Role requires extended periods of sitting and screen time.
• Must be able to lift and carry document boxes weighing more than 20 lbs.
• 100% onsite work required.
• No travel requirements.

Pay

The expected wage range for this position at hiring is $21.15/hour - $25.00/hour. Individual base pay is determined by qualifications, skill level, experience, competencies, and other relevant factors.