The selected resources will provide operational support for document and records management activities at a pharmaceutical manufacturing site. The role is focused on maintaining accurate, organized, and readily retrievable GMP and business records to support day-to-day operations, regulatory compliance, and inspection readiness. Working in accordance with Good Documentation Practices (GDP) and site procedures, the Document Clerk ensures documents are properly filed, retained, protected, and accessible within approved systems, contributing to data integrity and effective information management across the organization.
B. SCOPE & RESPONSIBILITIES
Under limited supervision and in accordance with the laws, federal regulations, and applicable state and local policies, procedures and guidelines, this position has the following tasks and duties.
• Oversee the receipt, review, organization, and maintenance of company records and documents, ensuring proper classification and secure storage in accordance with site’s retention policies.
• Develop, implement, and maintain efficient digital and physical filing systems. Ensure all files are systematically organized, easily retrievable, and aligned with company and industry standards for good documentation practices.
• Examine documents for accuracy and completeness, making necessary corrections and updates to support data integrity and compliance with regulatory requirements.
• Update and preserve records and databases to facilitate operational processes and fulfill legal and regulatory obligations. Regularly audit files to ensure ongoing compliance.
• Respond promptly and professionally to documentation-related inquiries and requests from internal and external stakeholders, maintaining strict confidentiality and adherence to company requirements.
• Identify opportunities to enhance document control processes and implement best practices to streamline workflow and support continuous improvement initiatives.
• Support compliance with GMP and Good Documentation Practices (GDP).
• Ensure records are audit-ready for regulatory inspections.
• Support document control activities within approved electronic document management systems.
• Effective communication, positive interpersonal behaviors, and productive working relationships across teams.
C. MINIMUM REQUIREMENTS
• Associate degree or higher (completed) in Science.
• Experience in Electronic Document Management Systems (e.g. QualityDocs, Veeva)
• Strong alignment with GMP records management (e.g. Controlled printing, scanning, and archival processes)
in regulated environments
• Clear focus on organization, retention, accessibility, and confidentiality
• Excellent technical and quality documentation skills in English
• Able to use a logical, systematic approach to problem solving.
• Ability to manage multiple priorities and work independently with limited supervision.
• Strong communication, teamwork and collaboration skills.
• Available to work in rotational shifts to provide 24/7 manufacturing operations support.
**Weil Group is proud to be an Equal Employment Opportunity Employer.*