You haven't searched anything yet.
Job Title : Regulatory Operations Specialists - II (Associate)
Location : Millsboro, DE-Hybrid
Duration : 14 Months contract
Pay Rate: $26/hr on w2
Note:
• Hybrid schedule (require to be onsite for 3 days/week -Tuesday and Wednesday fixed) 3rd day can be discussed when on assignment.
Responsibilities:
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 liaises with departments such as Marketing, Pharmacovigilance and Technical Services to ensure compliance with established regulations.
Qualifications:
Title: Regulatory Affairs US Biologicals labeling specialist
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 Bachelor's, minimum 0-3 years of relevant experience within pharmaceutical labeling experience.
• With Master's minimum 0-2 year of relevant experience within pharmaceutical labeling experience.
• Require someone with 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, ADOBE.
Preferred/nice to have: Industry - Pharmaceutical Industry/Vaccine manufacturing/Medical and Biotechnology
Personality:
• Attention to details.
• Team Player.
• Able to follow directions.
• Can work independently once the trainings are complete.
• Able to make sure that regulations are met.
• Excellent communication and written skills.
• Open minded.
Comments/Special Instructions
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. • Looking for someone with labeling expertise in the pharmaceutical industry, vaccines 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, label design review. • Quality check for label content and formatting as per FDA guidelines. • Support the team with the review, revising labeling. • Attention to details. • Will prepare the label content following SOP’s and FDA regulations.
Contractor
IT Outsourcing & Consulting
$63k-82k (estimate)
06/19/2024
07/17/2024
eteaminc.com
SOUTH PLAINFIELD, NJ
500 - 1,000
1999
Private
BIPIN TAHKUR
$50M - $200M
IT Outsourcing & Consulting
eTeam provides industry-specific, SOW-based services, and global contingent workforce managementsolutions.
The job skills required for labeling specialist include Microsoft Office, Packaging, etc. Having related job skills and expertise will give you an advantage when applying to be a labeling specialist. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by labeling specialist. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for labeling specialist positions, which can be used as a reference in future career path planning. As a labeling specialist, it can be promoted into senior positions as a Logistics Clerk IV that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary labeling specialist. You can explore the career advancement for a labeling specialist below and select your interested title to get hiring information.