at Beacon Hill Staffing Group in Springfield, Illinois, United States
Job DescriptionBeacon Hill Life Sciences is actively recruiting for a Central Document Records Management Specialist to work a fully remote, contract assignment!
The contract assignment of 6 months to start, with possible extension to 12 months or may go perm depending on business need.
Salary is based on experience with range between $55/hour - $70/hour.
The Central Document Records Management Specialist role is a key individual contributor; responsible for developing, implementing, and managing the global/central document and records management programs throughout their lifecycle.
This role acts as a corporate champion of the Document Records Management program, and partners with other central/corporate team and site team members to ensure practices comply with the standards and applicable regulatory requirements, thus supporting operational and long-term growth objectives. This position will report to the Head of Document Records Management and GxP Training & Development.
Job Responsibilities will include:
- 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.
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Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records.
Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.
Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.
Learn more about Beacon Hill Staffing Group and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Life Sciences and Beacon Hill Technologies by visiting www.beaconhillstaffing.com .
We look forward to working with you!
Beacon Hill. Employing the Future™