Central Document Records Management Specialist - LD_1349432_46528583812_12-4658

at Beacon Hill Staffing Group in Springfield, Illinois, United States

Job Description

• Contributes to the development of corporate records management policy and the deployment of the records management governance program.
• Represents Quality on cross-functional projects and teams; ensures leveraging of Document Management capabilities and systems where appropriate.
• Leads the cross-functional community of practice to collaborate across the entire network on documentation development and associated training requirements.
• Develop templates and practices to assist, maintain, and scale-controlled documentation activities.
• Established the document periodic review calendar and collaborates with peers across the network to ensure adherence to scheduled activities.
• Ensures compliance with controlled document format and content.
• Mentors and coaches network Doc. Control personnel as needed in the establishment of standardized practices at all sites.
• Review records to ensure they comply with good documentation practices.
• Contributes to periodic Quality Management Reviews to assess the health of the Document and Records Management programs across all sites; identifies unfavorable trends and collaborates with manufacturing sites to ensure their timely mitigation.
• Works with the Central/Corporate Training and Development team to ensure training materials meet the needs of users at all levels of Document Control in the e-document system (eDMS) (Veeva).
• Facilitates eDMS and Document Records Management (DRM) training and information sessions as needed.
• Actively contributes to the configuration, validation, implementation, and lifecycle management of the Veeva eDMS partnering with Veeva system administrators, Veeva support, Business Process Owners, and more.

• Demonstrated experience in electronic document management system(s).
• Person must be willing to work in a 'startup' environment as things are constantly changing/
• Minimum of 5 years of experience in document records management in pharma or biomanufacturing industry
• Veeva experience required.
• Strong cGMP Quality knowledge, particularly in Quality Assurance; and demonstrate a spirit of continuous improvement to consistently enhance/modify existing processes/procedures.
• Demonstrated experience working in compliance with US and ICH GMP requirements, ensuring that Quality documentation meets standards expected by US and global regulatory authorities.
• Demonstrated experience supporting internal and external audits.
• Demonstrated experience with continuous quality improvement in response to business needs and regulatory inspections.
• Strong oral and written communication skills with strong technical writing expertise.
• Demonstrated ability to successfully execute responsibilities in a fast-paced environment.
• Proven ability to work as part of a well-integrated, networked team, and effectively collaborate across functional, organizational, and location boundaries.
• Demonstrated ability to meet challenging deadlines and manage multiple projects concurrently in a dynamic environment without sacrificing creativity, quality, or attention to detail.
• Technically adept with the willingness to learn new technology.
• Must be willing to mentor and coach others.

• 5+ years of document records management experience and previous work in the pharmaceutical and /or biomanufacturing industry.
• Demonstrated experience as an expert, administrator, and trainer on using Veeva QualityDocs Vault Electronic Management system (eDMS) as a member of the QA team.
• Bachelor's degree (a graduate degree is preferred) or equivalent related experience, preferably in Life Sciences.
• Experience in Quality Management Systems, e.g., Change Control, Deviations, and CAPAs.
• Demonstrated experience working in compliance with EU requirements in a QA role.
• Expert knowledge of Microsoft Office 365, especially Microsoft Word.