Documentation Coordinator Job

DOCUMENTATION COORDINATOR needed for a CONTRACT opportunity with Yoh's client located in PHOENIX, AZ.

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- Bachelors Degree
- Document Control Strategies
- Methods in A GMP controlled environment

WHAT YOU'LL BE DOING:

- Assist Deployment Leaders for 6 global sites with implementation of Product Controllership. This complex, cross-functional project is required to implement the Unique Device Identification (UDI) regulation mandated by the U.S. FDA before September 2016.
- Complete extensive on-line training in electronic Product Data Management systems, Product Controllership, and Design Controls.
- Attend conference calls during various time zones (Europe, Asia, and U.S.) and interface with colleagues from different countries and cultures.
- Interface with Design Engineering, Regulatory Affairs, Quality Assurance, Global Supply Chain, Advance Manufacturing Engineering, and Information Technology on implementation of new rating plate label design.
- Update Medical Device rating plate labels and customer-facing packaging to incorporate human readable (2D) data Matrix barcode.
- Create new part numbers, specifications, and release parts via electronic Product Data Management system.
- Generate Engineering Change Requests (ECRs) and Engineering Change Orders (ECOs) to update Bill of Materials (BOMs) with new parts and set attribute flags.
- Fulfill Product Controllership specific roles: Product Structure Leader (PSL), Configuration Management Specialist (CMS) and Technician (CMT) roles
- Work in multiple databases (PEGA, Deployment Engine, and MyWorkshop.
- Create and update commercial items
- Ensure completion of approved item creation and change requests
- Prepare Product Model lists and reports for product controllership conversion analysis (RDO Sort)
- Create and manage item requests and sub-workflows
- Launch, facilitate and consolidate technical & functional assessments and forward approved request(s) for execution
- Work with other functions as part of the orchestrated change process to ensure Product Model creation, maintenance, and change

WHAT YOU NEED TO BRING TO THE TABLE:

- Bachelor's degree and a minimum of five (5) years experience in a controlled environment.
- Two (2) years' experience using document control strategies or methods in a GMP controlled environment.
- Knowledge of MS Office products as well as the ability to learn new systems as required.
- Ability to communicate using English.
- Prior experience using word processing, spreadsheet, and presentation software.

IF THIS SOUNDS LIKE YOU, APPLY NOW!

RECRUITER: Rene Borst

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

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