Label Change Coordinator

Synectics - North Chicago, IL

Full-time | Contract

Description:

  • The Label Change Coordinator is responsible for the labeling change management of the company's marketed products in compliance with Ministries of Health, Regulatory, and production facility requirements.
  • Responsible for implementing and maintaining the effectiveness of the quality process by delivering the “perfect label” to our customers through an effective and efficient label change management process. The Perfect Label is defined as compliant with content requirements and timely implementation, both internal and external to the company.
  • Complete work according to established priorities, policies, practices and procedures to assure deliverables meet requirements.
  • Collaborate and communicate with key stakeholders to prioritize deliverables to successfully execute change requests.
  • Facilitates meetings with stakeholders as required.
  • Comply with the labeling change schedule to meet established timelines.
  • Communicate and negotiate exceptions to planned delivery dates.
  • Ensure adherence to right first-time principles from start of change to final artwork.
  • Evaluate the impact of a label change on associated labels and manufacturing operations.
  • Ensure completeness and accuracy for labeling changes.
  • Creation of labeling specifications and associated documentation if applicable.
  • Work closely with Label Center functions in the creation and verification of label artwork, mock ups utilized for regulatory submissions, and assist commercial, as required, in the development of label designs for packaging and labeling commodities.
  • Pull and evaluate GLM performance metrics and present to team lead.
  • Initiate root cause analysis and action plans, if necessary, for business need
  • Identifies continuous improvement opportunities.
  • Responsible for implementing Change Plan tasks.
  • Participate in local and global end to end labeling improvement projects.

Qualifications:

  • Bachelor’s Degree in Business / Engineering/Sciences preferred. Equivalent successful industry experience (minimum 4 years) can be considered (see below for guidance).
  • Minimum of 4 - 6 years combined experience from totals: Quality/Regulatory – 2 years, Operations – 2 years, Pharmaceutical/Device Regulations – 2 years.
  • Project management (multiple projects at a time) skills required
  • Strong written, verbal, and interpersonal communication skills required
  • Cross functional team collaboration skills required
  • Critical thinking skills required
  • Overall system experience required
  • Labeling experience in Pharmaceutical or Biotech industry preferred.
  • Must have a breadth of experience to establish and maintain credibility across functions, with stakeholders and with senior management.
  • Ability to motivate and influence others over whom they have no direct authority.
  • Knowledge of applicable regulations and standards affecting Pharmaceutical, Device, Device/Combo Products, specifically regulations and standards affecting the Packaging and Labeling Quality System.
  • Ability to logically reason, solve problems, and make decisions on key issues independently.
  • Self-motivated and strong focus on details and accuracy.
  • Strong interpersonal communication skills.

Since 1984, Synectics has been committed to aligning talented professionals with jobs they find challenging and fulfilling. Let us leverage our recruiting experience and our long-standing relationships with our clients to help you in your job search.

To view a comprehensive list of jobs offered by Synectics, please visit our website at www.synectics.com. We offer a wide variety of positions in cities throughout the United States.

Synectics is an Equal Opportunity Employer.

Job Types: Full-time, Contract

Benefits:

  • Health insurance
  • Dental insurance
  • Vision insurance
  • Retirement plan