Senior Labeling Specialist

Kelly is hiring a

Senior Labeling Specialist

for one of our clients in

San Diego, CA

100% onsite, 1st shift 8:00 am - 5:00 pm (flexible)
Pay: $35/hr
1 year contract (may be extended/converted)

Senior Level, Must have:
Execution of regulatory change control for device labels and package inserts for newly licensed products (systems include: Trackwise event tracking system)
Manages labeling inventory and issues labels to production teams via the SAP enterprise resource planning system
Maintaining regulatory change control for device master records, including product artwork, in accordance with 9 CFR requirements.
Experience a plus:
Product Lifecycle Management: MasterControl, Veeva Vault and Electronic Document Management System (EDMS).

Responsibilities:
Responsible for coordinating / processing product and process changes that range from simple to complex within an Electronic Data Management System. Responsible for interfacing with intra / inter – departmental associates on change management.
The scope of this role is responsible for carrying out the daily operations of the Change Management function as it pertains to product labeling, design control projects and device master records.
Works with Manufacturing, Marketing, Purchasing and Regulatory to provide an initial analysis of implementation timing, potential scrap costs and quantities of new labeling to be ordered.
Assists labeling change owners and junior staff with the creation of design change plans.
Responsible for updating design change logs and analyzing labeling changes for impact to Device Master Records.
Creates and maintains the Design History Files for assigned development projects per the approved procedures.
Review records for good DHF documentation practices, adherence to the DHF Document Change Control requirements and determine the need for Reference Pointer Forms.
Maintain the Master Action Item List and the DHF Index
Responsible for file maintenance and record keeping
Performs other duties & projects as assigned

Skills Needed
Excellent verbal and writing skills
Ability to handle multiple projects simultaneously and to prioritize tasks
Ability to follow detailed instructions, maintain accurate records, complete assignments in a thorough, conscientious fashion while adhering to company procedures and QSR compliance.
Advanced knowledge of Microsoft Office applications (Word, Excel, PowerPoint and Visio).
Experience with Adobe Acrobat Professional.
Familiar with federal and other regulations, e.g. QSR’s, ISO 13485, CMDR, IVDD
Demonstrates commitment to the development, implementation and effectiveness of their Quality Management System per ISO, FDA, and other regulatory agencies.
Understands and is aware of the quality consequences which may occur from the improper performance of their specific job.
Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
Follow all safety guidelines, manufacturing policies and procedures.
Operate under QSR compliance.

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