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Document Control Change Analyst

Company: Kelly Science, Engineering, Technology & Telecom
Location: Irvine
Posted on: November 22, 2022

Job Description:

Kelly Science and Clinical FSP is currently seeking a Document Control Change Analyst for a long-term engagement with one of our Medical Device clients. This position is hybrid in Irvine, CA. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.

POSITION SUMMARY Evaluate and take appropriate actions based on internal and external standards for products and procedures releases and modifications. Analyze and interpret data, using independent judgement to approve, reject, release, or rework change documentation submissions on a case by case basis. Analyze and review submissions based on product type, development lifecycle stage and the interpretation of the significance of the proposed change.
Adheres to environmental policy, procedures, and supports department environmental objectives.
ESSENTIAL FUNCTIONS 1 RESPONSIBILITIES Assists in creating and updating procedural documents and quality control documents. Examines documentation regularly for consistencies, gaps or errors. Works with relevant personnel to ensure accuracy of any revisions. Modifies test procedures and assists in converting to process maps. Identifies gaps to be resolved. Assists in reviewing proposals, contracts, regulatory, program and customer requirements for use in development of appropriate documentation in support of quality systems. Provides requested documents to support lawsuits and audits. Processes routine incoming documents, such as validation and verification protocols and reports. Assists in implementing document control systems and quality records procedures. Assists in the quality review and approval of change documentation. Verifies change implementation and approves closure of completed change orders. Works with cross functional product development teams and diverse departmentsMain areas of responsibilityl. Independently assess and judge proposed product and procedure changes for compliance to regulatory and business standards.2. Conduct final configuration verification prior to product release or change implementation in Document Management System and ERP system.3. Monitor, direct actions and/or escalate issues regarding the change processing status to meet project plan release deadlines.4. Guide change initiators in the development of accurate changes.5. Create and implement system processing improvements. Implement Quality improvement projects and other job duties as assigned. QUALIFICATIONS Minimum education required for competent performance: University/Bachelors Degree or Equivalent Minimum experience (number of month/years and type of work experience beyond formal education) required for competent performance: Generally Requires 1-2 Years Work Experience

Keywords: Kelly Science, Engineering, Technology & Telecom, Irvine , Document Control Change Analyst, Professions , Irvine, California

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