Archives Records Specialist

Position Summary:

The Archive Records Analyst supports the day-to-day administration of the local records archiving program. This role assists with the filing, tracking, retrieval, retention, and disposition of business and GMP-regulated paper records, including clinical, commercial, stability, raw material records, training and validation records as applicable.

• Support the intake, review, classification, labeling, and filing of business and GMP-regulated paper records.
• Maintain accurate paper records inventories, indexes, logs, and tracking tools.
• Store records in approved locations and ensure files are organized for efficient retrieval.
• Respond to routine records retrieval requests and provide archived records to authorized personnel.
• Perform routine quality checks to confirm that records are complete, properly labeled, and filed in the appropriate location.
• Track records-related activities, requests, transfers, and basic metrics for local management review.
• Support records retention and disposition activities in accordance with approved policies and procedures.
• Prepare records for transfer, storage, retrieval, or authorized destruction.
• Follow applicable records management, data integrity, privacy, security, and GMP requirements.
• Work with local business contacts to resolve routine archiving and records-related questions.
• Assist with local records management procedures, training materials, and communications.
• Use Microsoft Office applications and applicable tracking tools to complete daily work.
• Perform other duties as assigned.

• Associate degree, Bachelor's degree, or equivalent experience with at least 2 years of related experience; or
• High school diploma or equivalent with at least 4 years of related experience.
• Experience in records management, document control, paper filing, archiving, information management, or a related administrative function.
• Experience maintaining paper records, inventories, indexes, logs, or tracking systems.
• Experience working in a regulated environment, such as pharmaceutical, medical device, healthcare, quality, manufacturing, or regulatory operations, is preferred.
• Basic knowledge of records retention, filing, retrieval, and disposition practices.
• Familiarity with GMP requirements and controlled records is preferred.
• Strong attention to detail and organizational skills.
• Ability to follow established procedures and handle confidential information appropriately.
• Effective written and verbal communication skills.
• Basic proficiency with Microsoft Word, Excel, PowerPoint, and SharePoint.
• Ability to work effectively with local business partners and team members.