What are the responsibilities and job description for the Pharmaceutical Labeling Specialist(Associate )- PLSA25-19531 position at NavitsPartners?
Title : Pharmaceutical Labeling Specialist(Associate)
Location : Millsboro, DE 19966 (Hybrid; 3 days onsite with Tuesday and Wednesday fixed onsite)
Duration : 12 Months
Job Description
Minimum Education : Associate degree.
Preferred Education : Bachelor / Master's degree in Life Science.
Required Experience and Skills :
With Associate, minimum 5-7 years of relevant experience within pharmaceutical labelling experience.
With a Bachelor's, a minimum of 4-6 years of relevant experience in pharmaceutical labelling experience.
With a Master's minimum of 2-5 years of relevant experience in pharmaceutical labelling 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.
Personality :
Attention to detail.
Team Player.
Able to follow directions.
Can work independently once the training is complete.
Able to make sure that regulations are met.
Excellent communication and writing skills.
Open minded.
Must have :
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.
Responsibilities :
The client 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.
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 has context menu
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