Documentation Specialist

in Pharma Contract

Job Detail

  • Experience Level Entry Level
  • Degree Type Associate of Applied Science (AAS)
  • Employment Consulting
  • Working Type Hybrid
  • Job Reference 0000007838
  • Salary Type Hourly
  • Industry Medical Devices
  • Selling Points

    Exciting opportunity for a Project Coordinator with a medical device company!

Job Description

Responsibilities:

  • Provides project or program support to a functional group or business process.
  • Monitors program/project/system status, budgets and timetables.
  • Applies knowledge of and experience in company operations to assist in the development, implementation and administration of program/system guidelines and procedures.
  • Gathers and compiles information for reports.
  • Provides technical support, which may include program/system training, program/system documentation, data extraction, data review, tracking and coding.
  • Configuration Management:
    • Coordinates with Product Release and Configuration Assurance to prepare and route Engineering Change Orders and Change Actions (CO/CAs).
    • Fulfill internal customer requests for electronic versions of labeling.
    • Review parts prior to CO/CA release to ensure that all requirements for end item components and specifications are met, escalating issues as necessary.
    • Create and maintain end items in a product lifecycle management (PLM) system.
  • Quality System:
    • Coordinate with Product Release and Quality Systems to prepare and route product design documentation.
    • Perform change control audits of labeling and packaging components.
    • Perform proofs of labeling components and print vendor labeling.
    • Ensure personal understanding of all quality policy/system items that are applicable.
    • Follow all work/quality procedures to ensure quality system compliance and high-quality work.
  • eManuals Release:
    • Perform the eManuals Release Administrator (ERA) role by staging and releasing manuals to the eManuals website for the operating unit, including specifying the attributes.
    • Coordinate activities surrounding the qualification and release of eManuals for product launches.
    • Participate in user acceptance testing for the eManuals website as needed.
    • Follow established editorial guidelines for populating the attributes of eManual records on the eManuals website.
    • Participate in requirements definition and testing for new features on the eManuals website.
    • Work closely with internal and external partners to assist in troubleshooting problems with content, quality, or schedule and negotiate resolution of issues.

Requirements:

  • Requires full job knowledge of systems and procedures obtained through prior work experience or education.
  • Requires minimum of 2 years of relevant experience.
  • ShareAustin:

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