Document Control Change Analyst
Company: Kelly Science, Engineering, Technology & Telecom
Posted on: November 22, 2022
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
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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