Labeling Coordinator

Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals that help drive our vision. Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems.

Responsible for coordination and task execution for labeling of FDA regulated products and associated activities. Position works in collaboration with Regulatory Affairs, Marketing Communications, Document Control, and other departments as needed. Performs all tasks in compliance with the company's Quality System requirements.

Tasks/Duties/Responsibilities:

Prepare labeling files, label approval documents, and specifications using software programs including but not limited to Word, Excel, Adobe, Bartender and Visio. Maintain labeling files using company document control system.
• Collaborate with Regulatory Affairs, Document Control and Marketing Communications in the creation and approval of product labeling including layouts, translations, and label specifications and print proofs/films.
• Point person for communication between Meridian and contract manufacturers for labeling. Coordinate labeling activities between companies and ensure that activities and questions are completed in accordance with project timelines.
• Supports Meridian's Quality System and compliance with requirements of 21 CFR 820, 21 CFR Part 11, ISO13485 and applicable standards or guidance, as appropriate to assigned tasks.

Other Duties/Physical Requirements:

• Physical
  • Ability to walk up and down several flights of stairs throughout the workday in a multi-location facility.
• Other
  • Ability to work on a computer including repetitive use of a keyboard and mouse for long periods throughout the course of the workday.

Minimum Education or Equivalent Experience Required/Preferred:

• Bachelor's degree is required. College education in a business-related field is desirable.
• 2-3 years working in an FDA-regulated industry.
• Experience with label creation / revision in a regulated environment is highly preferred, but not required.

Competencies Required or Preferred:

• Ability to read, understand and follow all company SOPs and Guidelines.
• Computer proficiency (Word, Excel, Adobe, Bartender and Visio).
• Excellent interpersonal, organizational, written and oral communication skills.
• Must be well organized and able to meet strict deadlines and perform under pressure in a fast-paced environment.
• Must be able to work independently as well as collaboratively in a team setting with peers and other departments in a cross functional setting.
• Must be a self-starter, detail oriented and able to prioritize and balance both workload and timelines.

Required Travel %

• Will be required to travel to company headquarters for training if remote.