Document Control Specialist - Change Coordinator

  • location: Murrysville, PA
  • type: Contract
  • salary: $20 - $25 per hour

job description

Document Control Specialist - Change Coordinator

job summary:
Randstad Technologies is looking to add a Document Control Specialist to one of our top clients in the Murrysville, PA area. If you enjoy working in a cross-collaborative environment and have an eye for detail, please consider the following qualifications.

 
location: Murrysville, Pennsylvania
job type: Contract
salary: $20 - 25 per hour
work hours: 8am to 4pm
education: Bachelors
 
responsibilities:
  • Review FDA-compliant documents and packages for accuracy
  • Work with cross-functional teams to prepare Engineering Change Requests (ECR)
  • Create FDA-compliant ECO packages for all changes of varying complexity
  • Lead cross-functional ECO activities in order to meet agreed-upon deadlines
  • Identify and assist in the resolution of roadblocks preventing the release of change notices
  • Process change notices in SAP (releasing parts BOMs and production documents)
Key Areas of Responsibility

Material Master Management

  • Create and change material masters as required
  • Extend part numbers into SAP to support multiple manufacturing facilities and engineering change activities
  • Understand required settings to obsolete parts/ BOMs/ documents (including material implications)
  • Provide guidance in trouble-shooting and driving resolution of Material Master issues
Document Management

  • Review and approve documents for completeness and format accuracy prior to release
  • Understand document signature strategies
  • Complete document linkage at appropriate time
  • Ability to decipher information from generated reports
  • Review and approve Quality System Documents
  • Ability to retrieve historical information from current and legacy systems
  • Provide guidance in trouble-shooting and driving resolution of Document Management issues
ECR/ECO Management:

  • Support the creation of FDA compliant ECO packages for all changes of varying complexity including new product introductions utilizing Configuration Management principles
  • Work in cross-functional ECO related activities in order to meet agreed upon deadlines
  • Identify and assist in resolution of roadblocks preventing release of change notices
  • Determine appropriate part numbers/BOM Structures prior to release (assist in BOM review activities)
  • Support Pilot Run activities
  • Support change notices in SAP (releasing parts BOMs and production documents)
  • Ability to understand need and use for different BOM set ups (example: active, engineering, alternates)
  • Ability to review ECR / ECO hierarchy / content and understand requirements and use
  • Create and maintain lot tracking
  • Ability to manage Electronic Device History Record activities, as needed
  • Provide guidance in trouble-shooting and driving resolution of ECR/ECO Management issues
Training

  • Guide and assist peers in job function areas as needed
  • Facilitate training internal and external to the PLDM Department
  • Contribute to the development of necessary training materials
 
qualifications:
  • Experience level:
  • Minimum 3 years of experience
  • Education: Bachelors
 
skills:
  • Project Management

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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