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Labeling Specification Specialist

3 months ago

Grand Rapids, United States Redbock - an NES Fircroft company Full time

Labeling Specifications Specialist (Through end of February 2025 // Grand Rapids, MI): W2 Candidates only no third parties please.

Alternative Job Title: Document Control Specialist


LabelTop Skills:

  1. Medical device industry experience working with Medical Package Labeling
  2. Quality/Labeling Software of interest: MS Access, Adobe (Acrobat, Illustrator), LabelVision, QAD (or alternative ERP system), AutoCad
  3. Excellent proficiency in Microsoft Office software
  4. Configuration Assurance, Document Control or Record Management preferred


Description:

Responsible for creating and updating label files, maintaining and troubleshooting the labeling database and communicating label design and transfer requirements to external stakeholders. Responsible for reviewing electronic document change orders to ensure they are in compliance with defined procedures. This process includes approving, creating, controlling, revising, tracking, scanning, reproducing, retrieving and storing quality documents and records. This position works with employees within the company, as well as suppliers, and external customers to assist in processing change orders through the change control system. Also responsible for ensuring that all activities related to the configuration assurance processes are in compliance with applicable FDA regulations, ISO standards, company SOPs, corporate identity standards, and customer requirements.


Duties:

  • Supports internal customers with labeling issues including real-time label adjustments of artwork or print locations
  • Maintains the label database including updating files as dictated by change control process and troubleshooting labeling database issues
  • Leads and improves the label change control process in regards to electronic label file management
  • Ensures label database changes are updated simultaneously with document control changes
  • Works with the I.T. Department, Packaging, Operations, Project Managers and the Engineer team on the label change control process (Change Request, Design, QA Review, Testing, Change Approval, and Record Retention)
  • Communicates with external stakeholders on label design, artwork requirements, and transfer into the QMS
  • Processes electronic change orders ensuring all documentation requirements are in compliance with specifications and standards per requirements defined internally, with external customers, and applicable regulatory requirements; also, for approved change order, coordinates actions required for their completion
  • Facilitates the timely release and change of documentation with documentation authors and approvers (from many levels of the organization) according to project and production needs
  • Coordinates, designs, and/or provides technical support for the creation and/or modification of technical drawings and/or multilingual technical documents and labeling to internal and external customers
  • Interacts with various Company personnel and vendors to coordinate and process documentation for new products and existing products
  • Processes, distributes, and maintains released documents, including change orders, BOMS, Item Masters, Device Master Records, Specifications, etc.
  • Maintains and updates the ERP system in accordance with approved change orders
  • Protects and preserves current master documents, historical files, and ERP configuration settings
  • Performs ERP entries including the creation of, and updates to, Material Item Masters, BOMs, Routings, Combination lot information, and others as needed based on customer documentation and engineering input
  • Serves as a back-up for other functions or perform other duties, such as regulatory audit support or configuration assurance function training, as assigned


Knowledge/Education Required:

  • Bachelor's Degree within 1-2 years of experience in quality and labeling. Candidates from a regulated industry will be preferred


Preferred Experience:

  • Previous experience in Configuration Assurance, Document Control or Record Management preferred
  • Previous experience with bills of materials, component specifications and work with product/device labeling systems preferred
  • Previous experience in a Medical Device and/or FDA regulated industry preferred


Skills/Competencies

  • Excellent proficiency in Microsoft Office software
  • Strong attention to detail, able to produce error-free work
  • Ability to work in a highly organized manner while managing multiple priorities
  • Ability to learn and apply company SOPs as relates to documentation
  • Excellent written and verbal communication skills
  • Excellent interpersonal skills serving internal and external customers
  • Ability to follow both verbal and written instructions
  • Accuracy in filing skills required
  • Proofreading skills (grammar, usage, syntax, spelling)
  • Ability to prioritize tasks and work independently
  • Able to communicate effectively with a variety of people, including external business contacts
  • Trustworthiness in handling confidential and sensitive information
  • Team player with ability to work cross functionally with various departments
  • Completes assignments efficiently and timely
  • Ability to meet deadlines


Computer proficiency:

  • Previous work with electronic information management systems preferred
  • QAD or other ERP proficiency
  • Knowledge of computer software:
  • MS Access
  • MS Office
  • Adobe (Acrobat, Illustrator)
  • AutoCad
  • LabelVision