Label Designer - Rahway, United States - AA2IT

AA2IT Rahway, United States

4 days ago

Description

Job Description

Labeling Specialist within Animal Health

Must have:

• Regulatory labeling content review as per FDA guideline.
• Quality check of labeling content errors.
• Label artwork, label design review
• Support the preparation of labeling documents, coordinating labeling document submissions to regulatory bodies.

• Hybrid schedule

• Experience would be preferred over a degree.

• Looking for someone with labeling expertise in the pharmaceutical industry, vaccines manufacturing or GMP.

• Software: MS office Typical day:

• Very intensive label-oriented job

• Need someone to hit the ground running.

• Lot of label review and submission.

• Quality check for label content and formatting as per FDA guidelines.

• Support the team with the review, revising labeling.

Will review labels on packaging, container, carton boxes.

• Will prepare the label content following SOP's and FDA regulations.

Education: Associate/Bachelor of Life Science/Master's degree. Required Experience and Skills:

• With Associate, minimum 5 years of relevant experience within pharmaceutical labeling experience

• With Bachelor's, minimum 3 years of relevant experience within pharmaceutical labeling experience
•

With Master's minimum 2 years of relevant experience within pharmaceutical labeling experience

• Require someone with scientific background or familiarity with medical terminology.

• Proficient in standard computer programs such as Microsoft Office, Excel, Word, Outlook, and SharePoint.

• Excellent English oral and written communication skills and presentation skills.

• Industry - Pharmaceutical Industry/Vaccine manufacturing/Medical and Biotechnology

• 1 year assignment with possibility of extension

• Hybrid schedule (require to be onsite for 3 days/week -Tuesday and Wednesday fixed) 3rd day is optional.
• Manager will prefer someone with experience over a degree/education.

Responsibilities:

• Under general supervision, responsible for the preparation of high-quality labeling documents for submission to the US Food and Drug Administration (FDA).
• Ensure that product labeling is updated in accordance with FDA regulations and corporate guidelines.
• Ensure prompt availability of labels and artworks and liaises with departments such as Marketing, Pharmacovigilance and Technical Services to ensure compliance with established regulations.
• Maintain databases and team sites by ensuring updated and accurate information is uploaded.

Company DescriptionAA2IT is in this business to make you successful. Strategy, Execution and Value. There are too many businesses that have solid, well-thought-out strategies that sit in a drawer somewhere collecting dust. Executing on Strategy effectively and measuring what matters drives the value. We start with your business strategy, align technology strategy, and create a roadmap that gets your business value.

AA2IT is a global firm providing Staffing and IT Solutions. We are headquartered in Texas, delivering successful talent acquisition and technology services. We are fully digital organization with a people centric and a technology driven vision.

Company Description

AA2IT is in this business to make you successful. Strategy, Execution and Value. There are too many businesses that have solid, well-thought-out strategies that sit in a drawer somewhere collecting dust. Executing on Strategy effectively and measuring what matters drives the value. We start with your business strategy, align technology strategy, and create a roadmap that gets your business value.\r
\r
AA2IT is a global firm providing Staffing and IT Solutions. We are headquartered in Texas, delivering successful talent acquisition and technology services. We are fully digital organization with a people centric and a technology driven vision.

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