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Documentation Administrator

Company: BD
Location: Broken Bow
Posted on: January 15, 2022

Job Description:

Job Description Summary1.0JOB SUMMARY1.1This position is responsible for the overall administration and regulatory compliance of plant Quality System documentation, graphics, and artwork, as required by Federal, International, BD Integrated Diagnostic Solutions, Specimen Management (IDS, SM) standards and procedures. 1.2This position works in conjunction with other departments, BD plants, and the BD IDS, SM Unit to assure documentation is accurate and distributed as directed. Coordinates the Engineering Change Request/Order (ECR/O) process, within the System Applications and Products in Data Processing (SAP) software, ensures all required information/data is present in the ECR/O, and administers the effectivity dates of objects being revised. 1.3This position is responsible for the administration of artwork, graphics, and labeling to support BD IDS, SM product packaging. This position must assist in ensuring accuracy of artwork for the manufacturing of labels and coordinating labeling approvals.Job DescriptionBe part of something bigger!BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.Essential Functions:Providing support to ECR/O originators in preparation/routing/approval of objects and ECR/Os in the SAP System. - Reviews proposed changes to ensure correct use of standard formats and conventions. Working with engineering change requesters, to determine change implementation (ECO) strategies. Administration the ECR/O process through:

  • Interfacing with Division and plant personnel to coordinate ECR/Os.
  • Verifying that ECR/Os and all documentation conform to policies, procedures, and required formats.
  • Ensuring that appropriate plant personnel are notified of released ECR/Os and all applicable documentation.Certifying change packages are complete for release/implementation:
    • All necessary supporting documents and data objects are in place.
    • All affected controlled documents and master data objects have been reviewed and approved for adequacy by appropriate individuals
    • Releases controlled documents and master data objects for use.
    • Overseeing and directing the use of electronic documentation system for document control.Maintenance of hardcopy and electronic Document Centers:
      • Ensuring that the most current implemented version of specifications, procedures, drawings, etc., are readily accessible to all associates.
      • Review and maintenance of Device Master Documents and Plant and Departmental Policies/Procedures to ensure correct use of standard formats and conventions.
      • Document control auditing of monthly reports, three-year reviews, artwork, BD corporate and BD global documents, and external standards.
      • Management of the site work instruction program.
      • Acting as a change coordinator in BDs SAP Product Lifecycle Management (PLM) system.
      • Verifying that appropriate individuals are assigned to tasks in the ECR/O and material master data workflow processes, adjusting task assignments in coordination with core team and functional leaders and maintaining underlying design center matrix and related reviewer and approval matrices.
      • Coordinating and conducting Document Management System training for new associates as necessary.
      • Conducting training and/or notification of document control system users on system upgrades/enhancements. Providing input and direction for artwork requirements by working closely with site project coordinators, BD IDS, SM graphics department, and other BD Unit graphics departments. -
      • Collaboration with the site print shop associates to facilitate and assist with artwork and graphic issues to ensure that the labels are printed correctly. Communication with BD IDS, SM and Corporate personnel to update the library of BD IDS, SM graphic images (i.e. symbols, fonts).
      • Supporting site and/or BD IDS, SM projects and factory/manufacturing work orders by providing input and direction for artwork requirements.OTHER RESPONSIBILITIES:Other responsibilities of this position include but are not limited to:
        • Complies with, and responsible for enforcing, all local, state, federal and BD safety regulations, policies/procedures.
        • Complies with all local BD quality policies/procedures/practices through consistent application of sound Quality Assurance principles. -
        • Ensures compliance through appropriate communication, training, and education of sound Quality Assurance principles. -
        • Responsible for the activities and programs as defined for this position in the Quality Systems Manual - BD Broken Bow.
        • Performs other job related duties as assigned.
        • Observes all safety, environmental and quality system standards.
        • All requirements are subject to possible modification to reasonably accommodate individuals with disabilities. Some requirements may exclude individuals who pose a direct threat or significant risk to the health and safety of themselves or other employees.This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position. - Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by their facilitator. - Requirements are representative of minimum levels of knowledge, skills and/or abilities. - To perform this job successfully, the incumbent will possess the abilities or aptitudes to perform each duty proficiently. This document does not create an employment contract, implied or otherwise, other than an "at will" employment relationship.EDUCATION, EXPERIENCE AND SKILLS REQUIRED:Education
          • Associates Degree required or 3-5 years documentation administration experience.Experience
            • Possess a thorough working knowledge of word processing, spreadsheet and other computer based application.
            • Must be able to multi-task, possess excellent communication skills and work independently.
            • Prefer Working knowledge of Enterprise Resource Planning System and Document Management Systems.
            • Prefer a working knowledge in using a McIntosh based computer graphics system.Software Programs:
            • Adobe Illustrator
            • QuarkXPress
            • Familiar with packaging/labeling materials, packaging configurations, equipment and printing techniques. -
            • Familiar with regulatory labeling requirements for both internationally and Domestic products.
            • Has a knowledge base of the current regulatory and Quality Standards.Physical Requirements - Level 2Light Work: - Exerting up to 20 pound occasionally, and/or 10 pounds of force frequently, or negligible constantly. - Walking or standing to a significant degree, or sitting constantly and pushing/pulling controls.Mental RequirementsThis position must have strong verbal, written, analytical, persuasion and interpersonal skills. - - Organizational skills are required. - The ability to accept responsibility and perform duties with little or no direct supervision is required. - Communication skills adequate to communicate effectively with all Plant and Division R&D/Quality Assurance personnel are required.Equipment UseThis position must have the ability to operate office equipment such as a photocopier, calculator, and personal computer with a standard keyboard.Working Conditions
              • The position is subject to inside environmental conditions typically associated with an office environment.
              • This position may require minimal travel.SupervisionThis position reports directly to the Associate Manager Quality - Compliance.For many roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, weekly testing for COVID-19 may be available instead of vaccination. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. - Why join us?A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life's purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program - which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components - is designed to support the varying needs of our diverse and global associates. #LI-PROTo learn more about BD visit Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. Primary Work LocationUSA NE - Broken BowAdditional LocationsWork Shift

Keywords: BD, Lincoln , Documentation Administrator, Other , Broken Bow, Nebraska

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