Document Control Specialist

  • location: Murrysville, PA
  • type: Contract
  • salary: $22 - $25 per hour
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job description

Document Control Specialist

job summary:
We are looking for a Document Control Specialist for an opportunity in Murrysville, PA

Support EU MDR project from within the PLDM team. Work closely with Engineering, Regulatory, Project Management, and other cross-functional teams to prepare Engineering Change Request (ECR) packages and support Customer Master Data functions.

DESCRIPTION:

- 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 resolution of roadblocks preventing release of change notices

- Process change notices in SAP (releasing parts BOMs and production documents)

 
location: Murrysville, Pennsylvania
job type: Contract
salary: $22 - 25 per hour
work hours: 8 to 5
education: Bachelors
 
responsibilities:
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, approve and release 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:

  • Create FDA compliant ECO packages for all changes of varying complexity including new product introductions utilizing Configuration Management principles
  • Lead cross-functional ECO 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)
  • Lead Pilot Run activities
  • Process 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
Project Management

  • Lead applicable ECO activities as described above
 
qualifications:
COMPETENCIES/BEHAVIORS:

- Commitment to Quality

- Attention to Detail

- Self-responsibility

- Communication

- Interpersonal skills

- Teaming

- Comprehension of Instruction

- Time Competency

- Learning agility

- Customer Relations

- Initiative

 
skills: Education/Experience

  • Bachelors Degree or equivalent
  • 3+ years experience managing projects of varying complexity
  • Proficient in Microsoft Office applications (Excel, Word, PowerPoint)
Proficient SAP or equivalent. Knowledge of Configuration Management principles


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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