Quality Assurance Archivist

The Position

The Quality Assurance Archivist will be responsible for the preservation, organization, and management of our corporate archives, ensuring the protection and accessibility of critical historical and regulatory documentation. The Quality Assurance Archivist will ensure proper storage, retrieval, and eventual destruction of documentation supporting GxP related activities. This role is essential in supporting our company’s compliance efforts, historical record-keeping, and research initiatives.

Responsibilities

• Records Management: Oversee the archival collection of physical and digital documents, including historical records, research data, regulatory documents, product development files, marketing materials, and other corporate assets. Ensure documents are organized, cataloged, and indexed for easy retrieval.
• Digital Archive Development: Implement and maintain a digital archival system for electronic records, ensuring compatibility with current technologies and the company’s IT infrastructure. Convert physical records to digital formats where necessary and ensure proper metadata tagging.
• Compliance & Regulatory Support: Ensure that all records comply with regulatory requirements, including those set by health authorities such as the FDA, EMA, and other regulatory bodies. Assist in the management of records retention schedules and disposal protocols to meet legal and business requirements.
• Preservation: Develop strategies for the long-term preservation of physical and digital records. Maintain conditions for the safeguarding of valuable documents, including proper storage environments, and manage the restoration and conservation of damaged materials.
• Access & Retrieval: Serve as the primary point of contact for internal and external requests for archived materials. Provide efficient and timely access to historical records for various departments, including R&D, legal, marketing, and senior management.
• Archival Research & Reporting: Conduct research using the archived records to support business initiatives, corporate history projects, or external inquiries. Prepare reports, presentations, and summaries based on historical data as required by leadership or external stakeholders.
• Training & Support: Provide training and guidance to staff on best practices for records management and archiving. Promote awareness of archival resources and procedures across the company.
• Continuous Improvement: Regularly assess and improve the archival process, tools, and systems. Stay updated with industry best practices, emerging technologies, and legal changes related to record management.
• Additional duties as assigned.

Requirements:

• High School diploma
• An associate or bachelor’s degree in a related field is preferred but not required.
• At least three years of experience working in an FDA regulated environment in an archiving or document management role.
• Strong understanding of pharmaceutical regulations, intellectual property, and the importance of maintaining corporate history for regulatory and business purposes, including Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and/or Good Documentation Practices (GDP) regulations.
• Competent knowledge of and ability to use Microsoft Word and Excel.
• Proficiency with archival software and digital records management systems (e.g., Veeva Vault, OpenText, or other industry-specific tools). Familiarity with metadata standards, digital preservation techniques, and document scanning technologies.

Preferred: 

• Certification in Archives Management (e.g., Certified Archivist) or Records Management (e.g., Certified Records Manager).
• Experience with pharmaceutical regulatory filings and the lifecycle of drug development documentation.
• Familiarity with cloud-based archival and content management solutions.
• Ability to work with large volumes of information and maintain accurate, comprehensive, and organized records.
• Ability to multi-task and prioritize work tasks with minimal supervision.
• Excellent written and verbal communication skills, with the ability to interact with a wide range of internal stakeholders and external parties.
• Strong analytical and problem-solving skills, with the ability to adapt to changing business needs and regulatory requirements.