Document Management And Records Specialist

Requisition Id 12996

Document Management and Records Specialist:

Oak Ridge National Laboratory (ORNL) is seeking a Document Management and Records Specialist to support our world class radioisotope production program. The Isotope Science and Engineering Directorate's (ISED) Document and Records Management group in the Nonreactor Nuclear Facilities Division seeks to hire a Document and Records Management Specialist to process, maintain, retrieve, and disseminate information in support of records management activities for our Actinium-225 programs. This role will interact with records analysts, records specialists, and other UT-Battelle staff members to ensure records management policies and procedures are appropriately followed and to help maintain records.

This position will be deployed to an internal customer, the newly formed Isotope Processing and Manufacturing Division (IPMD), and will be physically located at the customer's location. This position will support IPMD's Actinium-225 programs. Document and records management for the Actinium-225 programs must comply with Current Good Manufacturing Practice (cGMP) regulations enforced by the Food and Drug Administration (FDA). IPMD is focused on the reliable delivery of radioisotope products. This work supports the largest radioisotope production and research portfolio within the Department of Energy (DOE) Office of Science for Isotope R&D and Production.

Major Duties/Responsibilities:

• Ensures procedures, technical documents, calculations, drawings, and many other documents and records (from internal and external sources) are properly, accurately, and timely processed, made available in appropriate project electronic document management systems, collaborative sites, or websites, and distributed to identified personnel in support of customer's activities.

• Ensures documents and records meet criteria (format, identification, and approvals) specified by customer prior to distribution. Coordinates with staff to correct any documents and records not meeting requirements.

• Indexes and files records (hard copy and electronic) using electronic document management system(s), including customer's systems.

• Maintains current information in databases, provides retrieval services from various systems, and maintains tracking or status of documents and records in process.

• Ensures quality of electronic documents and records by reviewing scanned and other electronic files for legibility and completeness.

• Provides support to management in the assembly of files for high-level meetings including retrieving, checking for updates, printing, organizing, labeling, and providing the associated electronic files, as requested.

• Maintains a reference library of the high-level meeting files and related documentation.

• Communicates and works with customer's staff (including remote members) to coordinate proper receipt and processing of records.

• Handles sensitive information, such as proprietary and export control documentation.

• Updates internal work instructions for document control/records management activities.

• Supports special projects as needed by the customer, such as reorganization of electronic files in systems, metadata cleanup, verification of records receipt and metadata accuracy, maintenance of special SharePoint collaborative sites, etc.

• Provides user training or assistance on system(s) usage and processes on an as-needed basis to customer and support staff.

• Contributes to internal and external reports for document control and related activities, as requested.

• Participates in continuous improvement assessments and reviews of procedures and processes.

• Coordinate cGMP training requirements with Training organization for all personnel involved with cGMP production activities.

• Facilitate the review process for documents, ensuring that stakeholder feedback is considered along with consistent formatting.

• Coordinate with Quality Representative to track status of changes controls, deviations, non-conformances, and corrective and preventative actions (CAPA).

• Coordinate with Performance Assurance Specialist to analyze document management metrics for trends, evaluate the effectiveness of metrics, and make report results.

• Participate in internal assessments, audits, investigations, and assist with corrective action implementation.

• Assist assessment teams in the evaluation of document management/records compliance.

• Ensure that the appropriate system is used to identify, report, and correct nonconforming items, services, or processes.

• Contribute to customer complaint investigations and ensures issues are documented and logged appropriately.

• Responsible for ensuring records are properly stored and maintained.

• Maintain a strong commitment to the implementation and perpetuation of values and ethics.

• Ensures compliance with environment, safety, health, and quality program requirements.

• Adjusts to changes and reprioritizing of work.

• Displays excellent human relations skills and utilizes good oral and written communication.

• Performs as a team member that has a high volume of activity, displaying characteristics of collaboration, flexibility, and dependability, while ensuring a high degree of accuracy.

• Any other duties as assigned that are desired to meet the needs of the project.

Qualifications/Skills Required:

• High school diploma and 5-7 years of records management experience or Associates degree in Business, English, Information Management, or related field and 3-5 years of experience with records management and document control activities, including indexing, scanning, tracking documents, performing quality checks, and distributing information; or an equivalent combination of education and experience.

• Experience using Microsoft Office products including Word, Excel, and Adobe Acrobat Professional software.

Qualifications/Skills Desired:

• Experience with cGMP document and record management.

• Experience in handling non-classified sensitive information.

• Experience with document management and/or product lifecycle management software.

This position will remain open for a minimum of 5 days after which it will close when a qualified candidate is identified and/or hired.

We accept Word (.doc, .docx), Adobe (unsecured .pdf), Rich Text Format (.rtf), and HTML (.htm, .html) up to 5MB in size. Resumes from third party vendors will not be accepted; these resumes will be deleted and the candidates submitted will not be considered for employment.

If you have trouble applying for a position, please email ORNLRecruiting@ornl.gov.

ORNL is an equal opportunity employer. All qualified applicants, including individuals with disabilities and protected veterans, are encouraged to apply. UT-Battelle is an E-Verify employer.

Nearest Major Market: Knoxville