30 days old
2018-03-192018-04-25

Change Specialist I, Documentation Services

Abbott
Pleasanton, CA

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

The Change Specialist I is responsible for analyzing and processing change requests in the designated PLM system, with a focus on document and part changes, with adherence to SOPs/WIs.  This includes communication with change originators on issues identified and how to correct them.  The Change Specialist I also assigns change implementation tasks, enters information into the ERP system, and releases the change request for use within the organization. The role is also involved in Records Management activities.

Responsibilities:

  • Assure Effective Change Order Administration Ensure that all change requests comply with procedure requirements. Coordinate and control the processing of all documentation change requests, procedures, and appropriate documentation Coordinate implementation of change requests with all affected areas/facilities.
  • Maintain accurate configuration control part numbers and revision level assignments. Maintain product configurations by ensuring accuracy of Bills of Materials. Control Device Master Records. Maintain item master accuracy by updating additions, deletions, and other changes as required
  • Assure effective documentation control administration Monitor and prioritize routine documentation activities and requests to ensure customer expectations are met. Train departmental employees as required. Distribute notifications and updated documents to applicable areas, as required Develop and maintain documentation procedures. Proofread documents for accuracy and adherence to policies, as necessary.
  • Provide customer support to Engineering projects Support Engineering projects to ensure accurate product configuration and documentation of new products. Support project teams to ensure change requests are implemented to meet deadlines. Support Custom Device Requests to ensure accurate documentation, as necessary.
  • Provide support to records management and archiving activities. Support Customer requests such as; retrieval of old history including down rev. documents and device history, provide copies of procedures and/or procedure books as necessary, update distribution lists etc., perform all records management archiving and retrieval processes.
  • Other Duties: Provide support to team activities of the Documentation Services department and any initiatives related to all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements

    Qualifications:

    • HS Graduate or Equivalent
    • 0 – 2 years of experience in a Document/Engineering Change Control role, preferably in a regulated industry
    • Requires basic Microsoft Office skills
    • Able to enter data provided by change originators into a PLM system
    • Must have strong interpersonal  skills
    • Able to contribute to a department problem-solving team
    • Ability to work in a geographically diverse business environment.
    • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
    • Strong verbal and written communications with ability to effectively communicate with change originators and other Documentation Services staff in the organization.
    • Multitasks, prioritizes and meets deadlines in timely manner.
    • Strong organizational and follow-up skills, as well as attention to detail.
    • Ability to maintain regular and predictable attendance.
    • Regularly scheduled overtime is a requirement of this position.
      Job Family: Operations Quality
      Division: CAHF Cardiac Arrhythmias & Heart Failure
      Travel: No
      Medical Surveillance: No
      Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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Change Specialist I, Documentation Services

Abbott
Pleasanton, CA

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Change Specialist I, Documentation Services

Abbott
Pleasanton, CA
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