Labeling Specialist

3 weeks ago


De Soto, United States NavitsPartners Full time
Job DescriptionJob Description

Position: Labeling Specialist
Location: DeSoto, KS 66018
Hybrid schedule (require to be onsite for 3 days/week -Tuesday and Wednesday fixed) 3rd day can be discussed when on assignment.
Duration: 14 months

Job Description: Client Animal Health is a Biotechnology Center of Excellence that manufactures, fills, packages and distributes vaccines for animals.

This position is responsible but is not limited to the following duties:

  • Prepare new/revised label packaging for regulatory submissions to the USDA and maintain regulatory documents to ensure site compliance.
  • Support regulatory filing submissions with the USDA for both domestic and international product packaging.
  • Independently work with internal stakeholders, regulated packaging processes, and system workflows to revise or draft new packaging for vaccine biologicals for both US (domestic) and international markets.
  • Ensure prompt availability of labels and artworks and liaise with departments such as Marketing, Pharmacovigilance, and Technical Services to ensure compliance with established regulations.

Must have:

  • Recent grad with a scientific background- excellent computer skills with ADOBE and office.
  • Regulatory labeling content review as per FDA guidelines.
  • Quality check of labeling content errors.
  • Label artwork, and label design review.
  • Support the preparation of labeling documents, coordinating labeling document submissions to regulatory bodies.
  • Looking for someone with labeling expertise in the pharmaceutical industry, vaccine manufacturing, or GMP.

Typical day:

  • Very intensive label-oriented job
  • Need someone to hit the ground running.
  • Label review and submission of labeling documents and artwork
  • Label artwork, and label design review.
  • Quality check for label content and formatting as per FDA guidelines.
  • Support the team with the review, and revising labeling.
  • Attention to detail.
  • Will prepare the label content following SOP's and FDA regulations.

Training: Training with the USDA regulations on packaging, ARTIS computer system, and internal processes and workflows for packaging submissions and filing maintenance.
Training Type: Corporate Development - Coaching

Qualifications:

  • Minimum Education: Associate degree.
  • Preferred Education: Bachelor/Master's degree in Life Science.

Required Experience and Skills:

  • With Associate, minimum 3-5 years of relevant experience within pharmaceutical labeling experience.
  • With a Bachelor's, a minimum of 0-3 years of relevant experience in pharmaceutical labeling experience.
  • With a Master's minimum of 0-2 years of relevant experience in pharmaceutical labeling experience.
  • Require someone with a scientific background or familiarity with medical terminology.
  • Require someone with excellent proofreading skills.
  • Proficient in standard computer programs such as Microsoft Office, Excel, Word, Outlook, SharePoint, and ADOBE.

Preferred/nice to have: Industry - Pharmaceutical Industry/Vaccine manufacturing/Medical and Biotechnology


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