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Quality System Document Control Administrator

Quality System Document Control Administrator

LancesoftWest Hills, CA, US
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Shift :  Monday to Friday 8am to 5pm

Duration : 06 Months

Pay range : $25-$25 / hr.

Onsite Job

The Quality System Document Control (QSDC) Administrator is responsible for handling all Quality System controlled documents (Standard Operating Procedures (SOPs), Work Instructions (WIs), Forms, Policies, Knowledge Assessments (KAs), among others). The QSDC Administrator will circulate and track the documents through the review, approval and distribution process. The QSDC Administrator will upload and link the documents into the Document and Training System.

Responsibilities

  • Maintain all controlled documents and assist company personnel with the creation and revision of all controlled documentation (i.E. SOPs, WIs, Forms, KAs, etc.).
  • Monitor shared mailbox and respond to company personnel for documents that require to be created, revised and / or inactivated.
  • Initiate the periodic review process for controlled documents by their due dates and associated metrics.
  • Ensure adherence to established templates and procedures.
  • Verify document change requests, perform review of documents for accuracy and consistency before circulating for approval.
  • Assist document authors with navigation in electronic document management system, formatting, and workflows of documents.
  • Store, manage, and track documents throughout entire lifecycle.
  • Scan, image, organize, and maintain documents.
  • Archive inactive records in accordance with the records retention schedule.
  • Assist with audit preparation and audit support as required.
  • Maintain curricula, learning plans, and training records, record training and learning events via the internal Training Management System.
  • Update internal Training Management System as needed to support internal Clients training requirements.
  • Run reports in the Training Management System and provide training data to functional areas for trending purposes as requested.
  • Manage creation and distribution of log books.
  • Troubleshoot issues found in the Training Management System and enter courses / tests e-learning content.
  • Support other business needs as required.
  • Present training on EDMS system to site employees
  • Regularly attend meetings regarding training and document systems

How will you get here?

Education

  • Associates Degree.

    • Knowledge, Skills, Abilities

  • A minimum of 3 years’experience in the pharmaceutical or related regulated industry.
  • Familiar with Quality Systems (change control, deviations, documentation management, and training system).
  • Ability to understand and implement priorities and workload and to establish strong collaborative relationships with peers.
  • Good communication, diplomacy skills and be able to work effectively with internal stakeholders.
  • Must be detailed oriented to detect errors or deficiencies when reviewing and releasing documents for approval.
  • Ability to work effectively within various electronic document templates and provide assistance and guidance to authors when requested in relation to these documents.
  • Experience with electronic Document Management Systems.
  • Experience with electronic Training Management Systems

    • Physical Requirements

  • This position requires standing, bending, reaching, walking and talking as well as exerting up to 20 pounds

    • Employee Benefits :

    At LanceSoft, full time regular employees who work a minimum of 30 hours a week or more are entitled to the following benefits :

  • Four options of medical Insurance
  • Dental and Vision Insurance
  • 401k Contributions
  • Critical Illness Insurance
  • Voluntary Permanent Life Insurance
  • Accident Insurance
  • Other Employee Perks

    • About LanceSoft

    LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch.

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    System Administrator • West Hills, CA, US